Sleep apnea multi-level surgery trial: long-term observational outcomes.

STUDY OBJECTIVES: The sleep apnea multi-level surgery (SAMS) randomized clinical trial showed surgery improved outcomes at 6 months compared to ongoing medical management in patients with moderate or severe obstructive sleep apnea (OSA) who failed continuous positive airway pressure therapy. This study reports the long-term outcomes of the multi-level surgery as a case series. METHODS: Surgical participants were reassessed >2 years postoperatively with the same outcomes reported in the main SAMS trial. Primary outcomes were apnea-hypopnea index (AHI) and Epworth sleepiness scale (ESS), with secondary outcomes including other polysomnography measures, symptoms, quality of life, and adverse events. Long-term effectiveness (baseline to long-term follow-up [LTFU]) and interval changes (6 month to LTFU) were assessed using mixed effects regression models. Control participants were also reassessed for rate of subsequent surgery and outcomes. RESULTS: 36/48 (75%) of surgical participants were reevaluated (mean (standard deviation)) 3.5 (1.0) years following surgery, with 29 undergoing polysomnography. AHI was 41/h (23) at preoperative baseline and 21/h (18) at follow-up, representing persistent improvement of -24/h (95% CI -32, -17; p < 0.001). ESS was 12.3 (3.5) at baseline and 5.5 (3.9) at follow-up, representing persistent improvement of -6.8 (95% CI -8.3, -5.4; p < 0.001). Secondary outcomes were improved long term, and adverse events were minor. Interval change analysis suggests stability of outcomes. 36/43 (84%) of the control participants were reevaluated, with 25 (69%) reporting subsequent surgery, with symptom and quality of life improvements. CONCLUSION: Multi-level upper airway surgery improves OSA burden with long-term maintenance of treatment effect in adults with moderate or severe OSA in whom conventional therapy failed. CLINICAL TRIAL: Multi-level airway surgery in patients with moderate-severe obstructive sleep apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true; ACTRN12614000338662.

Comparative Effectiveness of Supine Avoidance versus Continuous Positive Airway Pressure for Treating Supine-isolated Sleep Apnea: A Clinical Trial.

Rationale: About 20-35% of patients with obstructive sleep apnea (OSA) have supine-isolated OSA, for which supine sleep avoidance could be an effective therapy. However, traditional supine discomfort-based methods show poor tolerance and compliance to treatment and so cannot be recommended. Supine alarm devices show promise, but evidence to support favorable adherence to treatment and effectiveness at reducing excessive daytime sleepiness compared with continuous positive airway pressure (CPAP) remains limited. Objectives: To establish if alarm-based supine-avoidance treatment in patients with supine-isolated OSA is noninferior to CPAP in reducing daytime sleepiness. Methods: After baseline questionnaire administration and in-home supine-time and polysomnography assessments, patients with supine-isolated OSA and Epworth Sleepiness Scale scores ⩾8 were randomized to ⩾6 weeks of supine-avoidance or CPAP treatment, followed by crossover to the remaining treatment with repeat assessments. Noninferiority was assessed from change in Epworth Sleepiness Scale with supine avoidance compared with CPAP using a prespecified noninferiority margin of 1.5. Average nightly treatment use over all nights and treatment efficacy and effectiveness at reducing respiratory disturbances were also compared between treatments. Results: The reduction in sleepiness score with supine avoidance (mean [95% confidence interval], -1.9 [-2.8 to -1.0]) was noninferior to that with CPAP (-2.4 [-3.3 to -1.4]) (supine avoidance-CPAP difference, -0.4 [-1.3 to 0.6]), and the lower confidence limit did not cross the noninferiority margin of 1.5 (P = 0.021). Average treatment use was higher with supine avoidance compared with CPAP (mean ± standard deviation, 5.7 ± 2.4 vs. 3.9 ± 2.7 h/night; P < 0.001). Conclusions: In patients with supine-isolated OSA, vibrotactile supine alarm device therapy is noninferior to CPAP for reducing sleepiness and shows superior treatment adherence. Clinical trial registered with www.anzctr.org.au (ACTRN 12613001242718).

Volumetric magnetic resonance imaging analysis of multilevel upper airway surgery effects on pharyngeal structure.

STUDY OBJECTIVES: The Sleep Apnea Multilevel Surgery (SAMS) trial found that modified uvulopalatopharyngoplasty with tonsillectomy (if tonsils present) combined with radiofrequency tongue ablation reduced obstructive sleep apnea (OSA) severity and daytime sleepiness in moderate-severe OSA. This study aimed to investigate mechanisms of effect on apnea-hypopnea index (AHI) reduction by assessing changes in upper airway volumes (airway space, soft palate, tongue, and intra-tongue fat). METHODS: This is a case series analysis of 43 participants of 51 randomized to the surgical arm of the SAMS trial who underwent repeat magnetic resonance imaging (MRI). Upper airway volume, length, and cross-sectional area, soft palate and tongue volumes, and tongue fat were measured. Relationships between changes in anatomical structures and AHI were assessed. RESULTS: The participant sample was predominantly male (79%); mean ± SD age 42.7 ± 13.3 years, body mass index 30.8 ± 4.1 kg/m2, and AHI 47.0 ± 22.3 events/hour. There were no, or minor, overall volumetric changes in the airway, soft palate, total tongue, or tongue fat volume. Post-surgery there was an increase in the minimum cross-sectional area by 0.1 cm2 (95% confidence interval 0.04-0.2 cm2) in the pharyngeal airway, but not statistically significant on corrected analysis. There was no association between anatomical changes and AHI improvement. CONCLUSIONS: This contemporary multilevel upper airway surgery has been shown to be an effective OSA treatment. The current anatomical investigation suggests there are not significant post-operative volumetric changes associated with OSA improvement 6-month post-surgery. This suggests that effect on OSA improvement is achieved without notable deformation of airway volume. Reduced need for neuromuscular compensation during wake following anatomical improvement via surgery could explain the lack of measurable volume change. Further research to understand the mechanisms of action of multilevel surgery is required. CLINICAL TRIAL: This manuscript presents a planned image analysis of participants randomized to the surgical arm or the clinical trial multilevel airway surgery in patients with moderate-severe obstructive sleep apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=266019&isReview=true%20Australian%20New%20Zealand%20Clinical%20Trials%20Registry%20ACTRN12514000338662, prospectively registered on March 31, 2014.

Polysomnographic Predictors of Treatment Response to Cognitive Behavioral Therapy for Insomnia in Participants With Co-morbid Insomnia and Sleep Apnea: Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVE: Co-morbid insomnia and sleep apnea (COMISA) is a common and debilitating condition that is more difficult to treat compared to insomnia or sleep apnea-alone. Emerging evidence suggests that cognitive behavioral therapy for insomnia (CBTi) is effective in patients with COMISA, however, those with more severe sleep apnea and evidence of greater objective sleep disturbance may be less responsive to CBTi. Polysomnographic sleep study data has been used to predict treatment response to CBTi in patients with insomnia-alone, but not in patients with COMISA. We used randomized controlled trial data to investigate polysomnographic predictors of insomnia improvement following CBTi, versus control in participants with COMISA. METHODS: One hundred and forty five participants with insomnia (ICSD-3) and sleep apnea [apnea-hypopnea index (AHI) ≥ 15] were randomized to CBTi (n = 72) or no-treatment control (n = 73). Mixed models were used to investigate the effect of pre-treatment AHI, sleep duration, and other traditional (AASM sleep macrostructure), and novel [quantitative electroencephalography (qEEG)] polysomnographic predictors of between-group changes in Insomnia Severity Index (ISI) scores from pre-treatment to post-treatment. RESULTS: Compared to control, CBTi was associated with greater ISI improvement among participants with; higher AHI (interaction p = 0.011), less wake after sleep onset (interaction p = 0.045), and less N3 sleep (interaction p = 0.005). No quantitative electroencephalographic, or other traditional polysomnographic variables predicted between-group ISI change (all p > 0.09). DISCUSSION: Among participants with COMISA, higher OSA severity predicted a greater treatment-response to CBTi, versus control. People with COMISA should be treated with CBTi, which is effective even in the presence of severe OSA and objective sleep disturbance.

Effect of depression, anxiety, and stress symptoms on response to cognitive behavioral therapy for insomnia in patients with comorbid insomnia and sleep apnea: a randomized controlled trial.

STUDY OBJECTIVES: Patients with comorbid insomnia and sleep apnea (COMISA) report increased severity of depression, anxiety, and stress symptoms compared to patients with either insomnia or sleep apnea alone. Although cognitive behavioral therapy for insomnia (CBTi) is an effective treatment for COMISA, previous research suggests a reduced response to CBTi by patients with insomnia and depression, anxiety, and stress symptoms. Therefore, we used randomized controlled trial data to investigate the impact of depression, anxiety, and stress symptoms before treatment on changes in insomnia after CBTi vs control in patients with COMISA. METHODS: 145 patients with COMISA (insomnia as defined by the International Classification of Sleep Disorders, third edition and apnea-hypopnea index ≥ 15 events/h) were randomized to CBTi (n = 72) or no-treatment control (n = 73). One-week sleep diaries and standardized questionnaire measures of insomnia, sleepiness, fatigue, depression, anxiety, and stress were completed pretreatment and posttreatment. Mixed models were used to examine interactions between depression, anxiety, and stress symptoms before treatment, intervention-group (CBTi, control), and time (pretreatment, posttreatment) on insomnia symptoms. RESULTS: Approximately half of this COMISA sample reported at least mild symptoms of depression (57%), anxiety (53%), and stress (48%) before treatment. Patients reporting greater depression, anxiety, and stress symptoms before treatment also reported increased severity of insomnia, daytime fatigue, and sleepiness. Improvements in questionnaire and diary-measured insomnia symptoms improved during CBTi and were not moderated by severity of depression, anxiety, or stress symptoms before treatment (all interaction P ≥ .11). CONCLUSIONS: We found no evidence that symptoms of depression, anxiety, or stress impair the effectiveness of CBTi in improving insomnia symptoms in patients with COMISA. Patients with COMISA and comorbid symptoms of depression, anxiety, and stress should be referred for CBTi to treat insomnia and improve subsequent management of their obstructive sleep apnea. CLINICAL TRIAL REGISTRATION: Registry: Australian New Zealand Clinical Trials Registry; Name: Treating comorbid insomnia with obstructive sleep apnea (COMISA) study: A new treatment strategy for patients with combined insomnia and sleep apnea; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365184; Identifier: ACTRN12613001178730.

Cognitive behavioural therapy for insomnia reduces sleep apnoea severity: a randomised controlled trial.

Insomnia and obstructive sleep apnoea (OSA) frequently co-occur and may be causally related through sleep fragmentation and/or hyperarousal mechanisms. Previous studies suggest that OSA treatment can improve insomnia severity. However, the effect of insomnia treatment on OSA severity has not been investigated. We performed a randomised controlled trial to investigate the effect of cognitive behavioural therapy for insomnia (CBTi) on OSA severity, controlling for potential sleep-stage and posture effects. 145 patients with comorbid insomnia (International Classification of Sleep Disorders, 3rd Edn) and untreated OSA (apnoea-hypopnoea index (AHI) ≥15 events·h-1 sleep) were randomised to a four-session CBTi programme or to a no-treatment control. Overnight sleep studies were completed pre- and post-treatment to measure AHI, arousal index and sleep architecture, to investigate the effect of intervention group, time, sleep stage (N1-3 or REM) and posture (supine or nonsupine) on OSA severity. The CBTi group showed a 7.5 event·h-1 greater AHI difference (mean (95% CI) decrease 5.5 (1.3-9.7) events·h-1, Cohen's d=0.2, from 36.4 events·h-1 pre-treatment) across sleep-stages and postures, compared to control (mean increase 2.0 (-2.0-6.1) events·h-1, d=0.01, from 37.5 events·h-1 at pre-treatment; interaction p=0.012). Compared to control, the CBTi group also had a greater reduction in total number (mean difference 5.6 (0.6-10.6) greater overall reduction; p=0.029) and duration of nocturnal awakenings (mean difference 21.1 (2.0-40.3) min greater reduction; p=0.031) but showed no difference in the arousal index, or sleep architecture. CBTi consolidates sleep periods and promotes a 15% decrease in OSA severity in patients with comorbid insomnia and OSA. This suggests that insomnia disorder may exacerbate OSA and provides further support for treating insomnia in the presence of comorbid OSA.

The effect of cognitive and behavioral therapy for insomnia on week-to-week changes in sleepiness and sleep parameters in patients with comorbid insomnia and sleep apnea: a randomized controlled trial.

STUDY OBJECTIVES: While cognitive and behavioral therapy for insomnia (CBTi) is an effective treatment in patients with comorbid moderate and severe obstructive sleep apnea (OSA), there is concern that the bedtime restriction component of CBTi might dangerously exacerbate daytime sleepiness in such patients. We examined randomized controlled trial data to investigate the effect of OSA severity, and pretreatment daytime sleepiness on week-to-week changes in daytime sleepiness and sleep parameters during CBTi and no-treatment control. METHODS: One hundred and forty-five patients with untreated physician-diagnosed OSA (apnea-hypopnea index ≥15) and psychologist-diagnosed insomnia (ICSD-3) were randomized to a 4-week CBTi program (n = 72) or no-treatment control (n = 73). The Epworth sleepiness scale (ESS) and sleep diaries were completed during pretreatment, weekly CBTi sessions, and posttreatment. Effects of OSA severity, pretreatment daytime sleepiness, and intervention group on weekly changes in daytime sleepiness and sleep parameters were investigated. RESULTS: The CBTi group reported a 15% increase in ESS scores following the first week of bedtime restriction (M change = 1.3 points, 95% CI = 0.1-2.5, p = 0.031, Cohen's d = 0.27) which immediately returned to pretreatment levels for all subsequent weeks, while sleep parameters gradually improved throughout CBTi. There were no differences in changes in daytime sleepiness during treatment between CBTi and control groups or OSA-severity groups. Higher pretreatment ESS scores were associated with a greater ESS reduction during CBTi. CONCLUSIONS: CBTi appears to be a safe and effective treatment in the presence of comorbid moderate and severe OSA. Nevertheless, patients living with comorbid insomnia and sleep apnea and treated with CBTi should be monitored closely for increased daytime sleepiness during the initial weeks of bedtime restriction therapy. CLINICAL TRIAL REGISTRATION: Treating comorbid insomnia with obstructive sleep apnoea (COMISA) study: A new treatment strategy for patients with combined insomnia and sleep apnoea, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 365184 Australian New Zealand Clinical Trials Registry: ACTRN12613001178730. Universal Trial Number: U1111-1149-4230.

Sleep-Disordered Breathing in Patients with Motor Neurone Disease: One Size Does Not Fit all.

INTRODUCTION: Sleep-disordered breathing (SDB) in patients with motor neurone disease (MND) is normally attributed to hypoventilation due to muscle weakness. However, we have observed different patterns of SDB among MND patients referred for non-invasive ventilation, which do not appear to be explained by respiratory muscle weakness alone. AIM: The aim of this study was to examine the characteristics of SDB in MND. METHODS: This is a retrospective analysis of sleep studies (using polysomnography [PSG]), pulmonary function tests, and arterial blood gases in MND patients referred to a tertiary sleep medicine service for clinical review. Sleep apnoeas were characterised as obstructive or central, and to further characterise the nature of SDB, hypopnoeas were classified as obstructive versus central. RESULTS: Among 13 MND patients who had a diagnostic PSG, the mean ± SD age was 68.9 ± 9.8 years, BMI 23.0 ± 4.3 kg/m2, forced vital capacity 55.7 ± 20.9% predicted, and partial pressure of CO2 (arterial blood) 52.7 ± 12.1 mm Hg. A total of 38% of patients (5/13) showed evidence of sleep hypoventilation. The total apnoea/hypopnoea index (AHI) was (median [interquartile range]) 44.4(36.2-56.4)/h, with 92% (12/13) showing an AHI >10/h, predominantly due to obstructive events, although 8% (1/13) also showed frequent central apnoea/hypopnoeas. CONCLUSIONS: Patients with MND exhibit a wide variety of SDB. The prevalence of obstructive sleep apnoea (OSA) is surprising considering the normal BMI in most patients. A dystonic tongue and increased upper-airway collapsibility might predispose these patients to OSA. The wide variety of SDB demonstrated might have implications for ventilator settings and patients' outcomes.

Self-Reported Daytime Sleepiness and Sleep-Disordered Breathing in Patients With Atrial Fibrillation: SNOozE-AF.

BACKGROUND: Atrial fibrillation (AF) management guidelines recommend screening for symptoms of sleep-disordered breathing (SDB). We aimed to assess the role of self-reported daytime sleepiness in detection of patients with SDB and AF. METHODS: A total of 442 consecutive ambulatory patients with AF who were considered candidates for rhythm control and underwent polysomnography comprised the study population. The utility of daytime sleepiness (quantified by the Epworth Sleepiness Scale [ESS]) to predict any (apnea-hypopnea index [AHI] ≥ 5), moderate-to-severe (AHI ≥ 15), and severe (AHI ≥ 30) SDB on polysomnography was tested. RESULTS: Mean age was 60 ± 11 years and 69% patients were men. SDB was present in two-thirds of the population with 33% having moderate-to-severe SDB. Daytime sleepiness was low (median ESS = 8/24) and the ESS poorly predicted SDB, regardless of the degree of SDB tested (area under the curve: 0.48-0.56). Excessive daytime sleepiness (ESS ≥ 11) was present in 11.9% of the SDB population and had a negative predictive value of 43.1% and a positive predictive value of 67.5% to detect moderate-to-severe SDB. Male gender (odds ratio [OR]: 2.3, 95% confidence interval [CI]: 1.4-3.8, P = 0.001), obesity (OR: 3.5, 95% CI: 2.3-5.5, P < 0.001), diabetes (OR: 2.3, 95% CI: 1.2-4.4, P = 0.08), and stroke (OR: 4.6, 95% CI: 1.7-12.3, P = 0.002) were independently associated with an increased likelihood of moderate-to-severe SDB. CONCLUSIONS: In an ambulatory AF population, SDB was common but most patients reported low daytime sleepiness levels. Clinical features, rather than daytime sleepiness, were predictive of patients with moderate-to-severe SDB. Lack of excessive daytime sleepiness should not preclude patients from being investigated for the potential presence of concomitant SDB.

Cognitive and behavioral therapy for insomnia increases the use of continuous positive airway pressure therapy in obstructive sleep apnea participants with comorbid insomnia: a randomized clinical trial.

STUDY OBJECTIVES: Insomnia and obstructive sleep apnea (OSA) commonly co-occur which makes OSA difficult to treat with continuous positive airway pressure (CPAP). We conducted a randomized controlled trial in participants with OSA and co-occurring insomnia to test the hypothesis that initial treatment with cognitive and behavioral therapy for insomnia (CBT-i), versus treatment as usual (TAU) would improve insomnia symptoms and increase subsequent acceptance and use of CPAP. METHODS: One hundred and forty-five participants with OSA (apnea-hypopnea index ≥ 15) and comorbid insomnia were randomized to either four sessions of CBT-i, or TAU, before commencing CPAP therapy until 6 months post-randomization. Primary between-group outcomes included objective average CPAP adherence and changes in objective sleep efficiency by 6 months. Secondary between-group outcomes included rates of immediate CPAP acceptance/rejection, and changes in; sleep parameters, insomnia severity, and daytime impairments by 6 months. RESULTS: Compared to TAU, participants in the CBT-i group had 61 min greater average nightly adherence to CPAP (95% confidence interval [CI] = 9 to 113; p = 0.023, d = 0.38) and higher initial CPAP treatment acceptance (99% vs. 89%; p = 0.034). The CBT-i group showed greater improvement of global insomnia severity, and dysfunctional sleep-related cognitions by 6 months (both: p < 0.001), and greater improvement in sleep impairment measures immediately following CBT-i. There were no between-group differences in sleep outcomes, or daytime impairments by 6 months. CONCLUSIONS: In OSA participants with comorbid insomnia, CBT-i prior to initiating CPAP treatment improves CPAP use and insomnia symptoms compared to commencing CPAP without CBT-i. OSA patients should be evaluated for co-occurring insomnia and considered for CBT-i before commencing CPAP therapy. CLINICAL TRIAL: Treating comorbid insomnia with obstructive sleep apnea (COMSIA) study: A new treatment strategy for patients with combined insomnia and sleep apnea, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365184 Australian New Zealand Clinical Trials Registry: ACTRN12613001178730. Universal Trial Number: U1111-1149-4230.

Sleep Apnea Multilevel Surgery (SAMS) trial protocol: a multicenter randomized clinical trial of upper airway surgery for patients with obstructive sleep apnea who have failed continuous positive airway pressure.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is a serious and costly public health problem. The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients. Upper airway reconstructive surgery is available when medical treatments fail but randomized trial evidence supporting its use is limited. This protocol details a randomized controlled trial designed to assess the clinical effectiveness, safety, and cost-effectiveness of a multilevel upper airway surgical procedure for OSA. METHODS: A prospective, parallel-group, open label, randomized, controlled, multicenter clinical trial in adults with moderate or severe OSA who have failed or refused medical therapies. Six clinical sites in Australia randomly allocated participants in a 1:1 ratio to receive either an upper airway surgical procedure consisting of a modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction, or to continue with ongoing medical management, and followed them for 6 months. RESULTS: Primary outcomes: difference between groups in baseline-adjusted 6 month OSA severity (apnea-hypopnea index) and subjective sleepiness (Epworth Sleepiness Scale). Secondary outcomes: other OSA symptoms (e.g. snoring and objective sleepiness), other polysomnography parameters (e.g. arousal index and 4% oxygen desaturation index), quality of life, 24 hr ambulatory blood pressure, adverse events, and adherence to ongoing medical therapies (medical group). CONCLUSIONS: The Sleep Apnea Multilevel Surgery (SAMS) trial is of global public health importance for testing the effectiveness and safety of a multilevel surgical procedure for patients with OSA who have failed medical treatment. CLINICAL TRIAL REGISTRATION: Multilevel airway surgery in patients with moderate-severe Obstructive Sleep Apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true Australian New Zealand Clinical Trials Registry ACTRN12614000338662, prospectively registered on 31 March 2014.

The impact of ethnicity on the prevalence and severity of obstructive sleep apnea.

Obstructive sleep apnea (OSA) is a common disorder associated with multiple adverse health consequences and its prevalence is increasing in parallel with rising obesity trends. Early support for ethnic differences in OSA prevalence and severity has been derived from studies of relatively homogenous ethnic groups. However, between-study comparisons are problematic given differing methodologies. Recent large inter-ethnic studies examining different ethnic populations using standardized protocols support the notion that Chinese have an increased OSA prevalence and severity compared to those of European descent. Although the evidence is less clear, some data suggest that Hispanic/Mexican Americans also show higher rates of OSA, while OSA prevalence in African Americans is not dissimilar to that of populations of European ancestry. Of the anatomical traits underlying differences in OSA prevalence and severity between ethnic groups (i.e., obesity, fat distribution, and craniofacial structure) obesity appears to be the most important. The effect of ethnicity on non-anatomical factors (i.e., upper airway muscle responsiveness, arousal threshold, and loop gain) responsible for OSA severity and potentially prevalence is currently unknown and needs further research.

Comparing the Efficacy, Mask Leak, Patient Adherence, and Patient Preference of Three Different CPAP Interfaces to Treat Moderate-Severe Obstructive Sleep Apnea.

STUDY OBJECTIVES: To determine if the type of continuous positive airway pressure (CPAP) mask interface influences CPAP treatment efficacy, adherence, side effects, comfort and sleep quality in patients with moderate-severe obstructive sleep apnea (OSA). METHODS: This took place in a hospital-based tertiary sleep disorders unit. It is a prospective, randomized, crossover trial comparing three CPAP interfaces: nasal mask (NM), nasal mask plus chinstrap (NM-CS) and oronasal mask (ONM) each tried in random order, for 4 weeks. After each 4-week period, patient outcomes were assessed. Participants had a new diagnosis of obstructive sleep apneas. Forty-eight patients with moderate-severe OSA (32 males, mean ± standard deviation apnea-hypopnea index (AHI) 55.6 ± 21.1 events/h, age 54.9 ± 13.1 years, body mass index 35.8 ± 7.2 kg/m2) were randomized. Thirty-five participants completed the full study, with complete data available for 34 patients. RESULTS: There was no statistically significant difference in CPAP adherence; however, residual AHI was higher with ONM than NM and NM-CS (residual AHI 7.1 ± 7.7, 4.0 ± 3.1, 4.2 ± 3.7 events/h respectively, main effect P = .001). Patient satisfaction and quality of sleep were higher with the NM and NM-CS than the ONM. Fewer leak and mask fit problems were reported with NM (all chi-square P < .05), which patients preferred over the NM-CS and ONM options (n = 22, 9 and 4 respectively, P = .001). CONCLUSIONS: The CPAP adherence did not differ between the three different mask interfaces but the residual AHI was lower with NM than ONM and patients reported greater mask comfort, better sleep, and overall preference for a NM. A nasal mask with or without chinstrap should be the first choice for patients with OSA referred for CPAP treatment. CLINICAL TRIAL REGISTRATION: Registry: Australian and New Zealand Clinical Trials Registry, URL: https://www.anzctr.org.au, title: A comparison of continuous positive airway pressure (CPAP) interface in the control of leak, patient compliance and patient preference: nasal CPAP mask and chinstrap versus full face mask in patients with obstructive sleep apnoea (OSA), identifier: ACTRN12609000029291.

Erectile dysfunction is independently associated with apnea-hypopnea index and oxygen desaturation index in elderly, but not younger, community-dwelling men.

OBJECTIVE(S): To examine the association between obstructive sleep apnea (OSA) and other sleep indices using polysomnography (PSG) data and erectile dysfunction (ED) in a representative cohort of men. DESIGN: Cross-sectional. SETTING: Community-based. PARTICIPANTS: Aged 40+ years (n=734; mean age [SD], 60.8 [10.9]). MEASUREMENTS: Men with no prior OSA diagnosis who underwent in-home PSG (Embletta X100; 2010-11) and ED assessment (Global Impotence Rating) were selected. Un-adjusted and multi-adjusted regression models of ED were fitted against PSG measures, along with qualifying sociodemographic, lifestyle, and health-related covariates. Mediation effects were examined using the Baron-Kenny method. RESULTS: Of the men examined, 24.7% (n=181) had ED, most notably in men older than 65years (cf. men 35-49 and 50-64years; P<.001). There was no significant association between ED and any of the PSG measures for allaged men. Given an observed ageinteraction within OSA categories (P=.005), analyses were repeated in age-stratified samples (<65 years; 65+ years). In men younger than 65years, only severe OSA was found to have an association with ED (2.01; 1.13-4.69) in unadjusted models. For men aged 65+ years, an independent association with ED was found for apnea-hyponea index (AHI; 1.55;1.02-2.36), moderate (AHI:10.0-19.9; 1.79;1.18-2.43), and severe (AHI:20.0+; 4.84;2.56-9.93) OSA, and oxygen desaturation index (ODI; both continuous [1.48;1.03-1.99] and >16 seconds [2.79;1.23-6.32]). The effect of AHI on ED was shown to be primarily mediated through ODI (63.4%, Sobel P value=.29). CONCLUSIONS: In younger, community-based men, there appeared no independent relationship between objective measures of sleep and ED. However, there appears a strong, independent relationship between OSA, ODI, and ED in men 65 years and older.

Chronic Kidney Disease and Sleep Apnea Association of Kidney Disease With Obstructive Sleep Apnea in a Population Study of Men.

Study Objectives: To determine the relationship between obstructive sleep apnea (OSA) and chronic kidney disease (CKD). Previous population studies of the association are sparse, conflicting and confined largely to studies of administrative data. Methods: Cross-sectional analysis in unselected participants of the Men Androgens Inflammation Lifestyle Environment and Stress (MAILES) study, aged >40 years. Renal data were available for 812 men without a prior OSA diagnosis who underwent full in-home polysomnography (Embletta X100) in 2010-2011. CKD was defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 or eGFR≥60 and albuminuria (albumin-creatinine ratio ≥3.0 mg/mmol). Results: CKD (10.5%, n = 85 [Stage 1-3, 9.7%; Stage 4-5, 0.7%]) of predominantly mild severity showed significant associations with OSA (apnea-hypoapnea index [AHI] ≥ 10): odds ratio (OR) = 1.9, 95% confidence interval (CI): 1.02-3.5; severe OSA (AHI ≥ 30/h): OR = 2.6, 95% CI: 1.1-6.2; and respiratory-related arousal index: ≥7.6/h, OR = 2.3, 95%CI: 1.1-4.7; but not measures of hypoxemia after adjustment for age, hypertension, diabetes, smoking, obesity, and NSAID use. There was no association of CKD with daytime sleepiness. In men with CKD, those with OSA were not significantly more likely to report symptoms (sleepiness, snoring, and apneas) or be identified with the STOP OSA screening questionnaire, compared to men without OSA. Conclusions: Predominantly mild CKD is associated with severe OSA and arousals. Further population studies examining the longitudinal relationship between CKD and OSA are warranted. Better methods are needed to identify OSA in CKD which may have few symptoms.

Predictors of obstructive sleep apnoea in patients admitted for acute coronary syndrome.

Identifying undiagnosed obstructive sleep apnoea (OSA) patients in cardiovascular clinics could improve their management. Aiming to build an OSA predictive model, a broad analysis of clinical variables was performed in a cohort of acute coronary syndrome (ACS) patients.Sociodemographic, anthropometric, life-style and pharmacological variables were recorded. Clinical measures included blood pressure, electrocardiography, echocardiography, blood count, troponin levels and a metabolic panel. OSA was diagnosed using respiratory polygraphy. Logistic regression models and classification and regression trees were used to create predictive models.A total of 978 patients were included (298 subjects with apnoea-hypopnoea index (AHI) <15 events·h-1 and 680 with AHI ≥15 events·h-1). Age, BMI, Epworth sleepiness scale, peak troponin levels and use of calcium antagonists were the main determinants of AHI ≥15 events·h-1 (C statistic 0.71; sensitivity 94%; specificity 24%). Age, BMI, blood triglycerides, peak troponin levels and Killip class ≥II were determinants of AHI ≥30 events·h-1 (C statistic of 0.67; sensitivity 31%; specificity 86%).Although a set of variables associated with OSA was identified, no model could successfully predict OSA in patients admitted for ACS. Given the high prevalence of OSA, the authors propose respiratory polygraphy as a to-be-explored strategy to identify OSA in ACS patients.

Sleep health of Australian adults in 2016: results of the 2016 Sleep Health Foundation national survey.

OBJECTIVE: To measure the prevalence and social impacts of sleep problems in Australia. DESIGN: Cross-sectional national adult online survey. SETTING: Community-based sample. PARTICIPANTS: Australian adults ≥18 years, n=1011. RESULTS: Self-reported inadequate sleep, of either duration or quality, and its daytime consequences affect 33%-45% of adults. Diagnosed sleep apnea is reported by 8%, significant insomnia by 20%, and restless legs by18% of adults. Besides specific clinical sleep disorders, poor sleep habits were common. Average reported sleep time is 7 hours, although 12% sleep less than 5½hours and 8% over 9 hours. Three-quarters (76%) of those who sleep less than 5½hours report frequent daytime impairment or sleep-related symptoms. Frequent, loud snoring is reported by 24% of men and 17% of women. Among these, 70% report daytime impairment or other sleep-related symptoms. Twenty-six percent report Internet use most or every night just before bed and frequent sleep difficulties or daytime impairments. Similarly, 16% of working adults do work just before bed and also have frequent sleep difficulties or daytime sleep-related symptoms. Younger adults (18-34 years) sleep around 1 hour longer before non-work days than working days compared with 18 minutes in older age groups. In the past 3 months, 29% of adults report making errors at work due to sleepiness or sleep problems. Driving while drowsy at least every month is reported by 29% of people, 20% have nodded off while driving, and 5% have had an accident in the past year because they dozed off. CONCLUSION: Sleep problems and daytime consequences are endemic among Australian adults. A focus on healthy sleep at a policy level as well as increased clinician and public awareness may be warranted.

Physician Decision Making and Clinical Outcomes With Laboratory Polysomnography or Limited-Channel Sleep Studies for Obstructive Sleep Apnea: A Randomized Trial.

BACKGROUND: The clinical utility of limited-channel sleep studies (which are increasingly conducted at home) versus laboratory polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA) is unclear. OBJECTIVE: To compare patient outcomes after PSG versus limited-channel studies. DESIGN: Multicenter, randomized, noninferiority study. (Australian New Zealand Clinical Trials Registry: ACTRN12611000926932). SETTING: 7 academic sleep centers. PARTICIPANTS: Patients (n = 406) aged 25 to 80 years with suspected OSA. INTERVENTION: Sleep study information disclosed to sleep physicians comprised level 1 (L1) PSG data (n = 135); level 3 (L3), which included airflow, thoracoabdominal bands, body position, electrocardiography, and oxygen saturation (n = 136); or level 4 (L4), which included oxygen saturation and heart rate (n = 135). MEASUREMENTS: The primary outcome was change in Functional Outcomes of Sleep Questionnaire (FOSQ) score at 4 months. Secondary outcomes included the Epworth Sleepiness Scale (ESS), the Sleep Apnea Symptoms Questionnaire (SASQ), continuous positive airway pressure (CPAP) compliance, and physician decision making. RESULTS: Change in FOSQ score was not inferior for L3 (mean difference [MD], 0.01 [95% CI, -0.47 to 0.49; P = 0.96]) or L4 (MD, -0.46 [CI, -0.94 to 0.02; P = 0.058]) versus L1 (noninferiority margin [NIM], -1.0). Compared with L1, change in ESS score was not inferior for L3 (MD, 0.08 [CI, -0.98 to 1.13; P = 0.89]) but was inconclusive for L4 (MD, 1.30 [CI, 0.26 to 2.35; P = 0.015]) (NIM, 2.0). For L4 versus L1, there was less improvement in SASQ score (-17.8 vs. -24.7; P = 0.018), less CPAP use (4.5 vs. 5.3 hours per night; P = 0.04), and lower physician diagnostic confidence (P = 0.003). LIMITATION: Limited-channel studies were simulated by extracting laboratory PSG data and were not done in the home. CONCLUSION: The results support manually scored L3 testing in routine practice. Poorer outcomes with L4 testing may relate, in part, to reduced physician confidence. PRIMARY FUNDING SOURCE: National Health and Medical Research Council and Repat Foundation.

Developing a successful treatment for co-morbid insomnia and sleep apnoea.

Insomnia and sleep apnoea are the two most common sleep disorders, found in 6% and 23-50% of the general population respectively. These disorders also frequently co-occur, with 39-58% of sleep apnoea patients reporting symptoms indicative of co-morbid insomnia. When these disorders co-occur, clinicians are faced with difficult treatment decisions, patients experience the additive detrimental impacts of both disorders, and the effectiveness of discrete treatments for each disorder may be impaired. A common finding is that co-morbid insomnia and sleep apnoea (COMISA) is more difficult to treat than either disorder presenting alone. Co-morbid insomnia reduces the initial acceptance of, and later adherence to, continuous positive airway pressure (CPAP) therapy for obstructive sleep apnoea. This has resulted in recent recommendations that treatment approaches should initially target COMISA patients' insomnia to remove this barrier to CPAP treatment, and improve patient outcomes. However, no randomised controlled trial outcomes investigating this treatment approach currently exist. The current article aims to review and integrate recent research examining the prevalence, characteristics, and theoretical mechanistic relationships between co-occurring insomnia and OSA, and discuss previous treatment attempts.

A novel sleep optimisation programme to improve athletes' well-being and performance.

OBJECTIVES: To improve well-being and performance indicators in a group of Australian Football League (AFL) players via a six-week sleep optimisation programme. DESIGN: Prospective intervention study following observations suggestive of reduced sleep and excessive daytime sleepiness in an AFL group. METHODS: Athletes from the Adelaide Football Club were invited to participate if they had played AFL senior-level football for 1-5 years, or if they had excessive daytime sleepiness (Epworth Sleepiness Scale [ESS] >10), measured via ESS. An initial education session explained normal sleep needs, and how to achieve increased sleep duration and quality. Participants (n = 25) received ongoing feedback on their sleep, and a mid-programme education and feedback session. Sleep duration, quality and related outcomes were measured during week one and at the conclusion of the six-week intervention period using sleep diaries, actigraphy, ESS, Pittsburgh Sleep Quality Index, Profile of Mood States, Training Distress Scale, Perceived Stress Scale and the Psychomotor Vigilance Task. RESULTS: Sleep diaries demonstrated an increase in total sleep time of approximately 20 min (498.8 ± 53.8 to 518.7 ± 34.3; p < .05) and a 2% increase in sleep efficiency (p < 0.05). There was a corresponding increase in vigour (p < 0.001) and decrease in fatigue (p < 0.05). CONCLUSIONS: Improvements in measures of sleep efficiency, fatigue and vigour indicate that a sleep optimisation programme may improve athletes' well-being. More research is required into the effects of sleep optimisation on athletic performance.