Sleep Irregularity and the Incidence of Type 2 Diabetes: A Device-Based Prospective Study in Adults.

OBJECTIVE: To prospectively examine the association between device-measured sleep regularity and incidence of type 2 diabetes (T2D) in a population-based sample of adults. We also examined if meeting sleep duration recommendations attenuated or eliminated the effects of irregular sleep on T2D. RESEARCH DESIGN AND METHODS: We conducted a prospective cohort study of adults aged 40-79 years participating in the UK Biobank accelerometer substudy. Participants wore wrist-attached accelerometers for a duration of 7 days, which was used to compute the Sleep Regularity Index (SRI). Participants were categorized as irregular (SRI <71.6), moderately irregular (SRI between 71.6 and 87.3), and regular (SRI >87.3) sleepers. T2D diagnosis was obtained through self-reports and health records. RESULTS: We analyzed data from 73,630 individuals observed for 8 years, without a history of T2D and without an event in the first year of follow-up. Compared with regular sleepers, irregular (hazard ratio [HR] 1.38; 95% CI 1.20-1.59) and moderately irregular sleepers (HR 1.35; 95% CI 1.19-1.53) were at higher risk of T2D incidence. Dose-response analyses treating SRI as a continuous measure showed higher T2D incidence with SRI scores <80. Meeting current sleep duration recommendations did not counteract the adverse effects of irregular (HR 1.35; 95% CI 1.09-1.66) or moderately irregular (HR 1.29; 95% CI 1.08-1.54) sleep on T2D incidence. CONCLUSIONS: Moderate and high sleep irregularity were deleteriously associated with T2D risk, even in participants who slept ≥7 h per night. Future sleep interventions will need to pay more attention to consistency in bedtimes and wake-up times, in addition to sleep duration and quality.

Phenotypic Characterisation of Obstructive Sleep Apnoea in Acute Coronary Syndrome.

BACKGROUND: Recent neutral randomised clinical trials have created clinical equipoise for treating obstructive sleep apnoea (OSA) for managing cardiovascular risk. The importance of defining the links between OSA and cardiovascular disease is needed with the aim of advancing the robustness of future clinical trials. We aimed to define the clinical correlates and characterise surrogate cardiovascular markers in patients with acute coronary syndrome (ACS) and OSA. METHOD: Overall, 66 patients diagnosed with ACS were studied. Patients underwent an unattended polysomnogram after hospital discharge (median [interquartile range] 62 [37-132] days). The Epworth Sleepiness Scale, Berlin, and STOP-BANG questionnaires were administered. Surrogate measures of vascular structure and function, and cardiovascular autonomic function were conducted. Pulse wave amplitude drop was derived from the pulse oximetry signals of the overnight polysomnogram. RESULTS: OSA (apnoea-hypopnea index [AHI] ≥5) was diagnosed in 94% of patients. Moderate-to-severe OSA (AHI≥15) was observed in 68% of patients. Daytime sleepiness (Epworth Sleepiness Scale ≥10) was reported in 17% of patients. OSA screening questionnaires were inadequate to identify moderate-to-severe OSA, with an area under the receiver operating characteristic curve of approximately 0.64. Arterial stiffness (carotid-femoral pulse wave velocity, 6.1 [5.2-6.8] vs 7.4 [6.6-8.6] m/s, p=0.002) and carotid intima-media thickness (0.8 [0.7-1.0] vs 0.9 [0.8-1.0] mm, p=0.027) was elevated in patients with moderate-to-severe OSA. After adjusting for age, sex and body mass index, these relationships were not statistically significant. No relationships were observed in other surrogate cardiovascular markers. CONCLUSIONS: A high prevalence of OSA in a mostly non-sleepy population with ACS was identified, highlighting a gross underdiagnosis of OSA among cardiovascular patients. The limitations of OSA screening questionnaires highlight the need for new models of OSA screening as part of cardiovascular risk management. A range of inconsistent abnormalities were observed in measures of vascular structure and function, and these appear to be largely explained by confounding factors. Further research is required to elucidate biomarkers for the presence and impact of OSA in ACS patients.

Monitoring the sleep health of adults: a scoping review of routine national surveillance systems.

Study Objectives: The aims of this review were to identify existing national surveillance systems monitoring one or more domains of sleep health in adults, and to describe the specific sleep health indicators used. Methods: We systematically searched the gray and peer-reviewed literature for routinely conducted cross-sectional and longitudinal nationally representative health surveys that included the assessment of at least one domain of sleep health. The methodology involved: (1) targeted searches of the websites of national and international health agencies and statistics departments for 199 countries, (2) country-specific customized internet searches, and (3) country-specific electronic database searches of PubMed. Results: A total of 19 762 records were identified from both the gray and peer-reviewed literature. Sleep health surveillance at the national level was conducted by 51 countries (25.6%) across 69 national health surveys. Sleep quality (96.1% of countries that surveilled sleep) was the most frequently assessed followed by sleep duration (27.5%), sleep medication use (25.5%), sleep disorders (17.6%), daytime alertness (15.7%), sleep satisfaction (15.7%), and sleep timing (7.8%). Additionally, 34.8% of the surveys utilized multiple sleep health indicators. Conclusions: This study identified three significant gaps in the coverage of sleep health within national surveillance systems. Limited population sleep data in low- and middle-income countries, inconsistent use of sleep-related items in surveys and questionnaires, and substantial variability in the definitions of sleep health indicators. Advocacy for the inclusion of sleep health within national surveillance systems may be warranted given the important role sleep plays in public health.

Impact of CPAP Termination on Permanent Work Disability in Obstructive Sleep Apnea: A French Nationwide ALASKA Database Analysis.

RATIONALE: Three-year continuous positive airway pressure (CPAP) therapy termination rates are up to 50%, and therapy termination is associated with higher all-cause mortality and incident cardiovascular event risk. OBJECTIVE(S): This study investigated the impact of CPAP therapy termination in the first year on long sick leave leading to permanent work disability in patients with obstructive sleep apnea (OSA) based on data from the nAtionwide cLAimS data laKe for sleep Apnoea (ALASKA). METHODS: French national health insurance reimbursement system (SNDS) data were analyzed for all adults with OSA aged ≤62 years who started CPAP therapy in France in 2015/2016. CPAP therapy termination was defined as the cessation of CPAP reimbursements triggered by the respiratory physician/sleep specialist in charge of follow-up. Individuals who terminated therapy were compared with those who continued to use CPAP. The primary outcome was sick leave ultimately leading to permanent work disability. A multivariable Finn and Gray model, adjusted for age, sex, cardiovascular/metabolic comorbidities, depression, and CPAP prescriber clinical specialty was used to assess the risk of long-term sick leave leading to permanent work disability over 3 years' follow-up. RESULTS: The analysis included 174,270 individuals (median age 52.0 years [interquartile range 44.0-57.0], 67.5% male). The 1-year CPAP therapy termination rate was 22.3%. The proportion of individuals with long-term sick leave leading to permanent work disability was significantly higher in the CPAP termination versus continuation group (0.60% vs. 0.52%; p=0.042). In an adjusted multivariable Cox model, CPAP termination was associated with an increased risk of permanent work disability (hazard ratio [HR] 1.21, 95% confidence interval [CI] 1.04-1.41; p=0.01), primarily in the subgroup aged >55 years (HR 1.41, 95% CI 1.06-1.87; p=0.02). CONCLUSIONS: These real-world data from a comprehensive, unbiased database highlight the potential occupational impact of CPAP therapy termination.

A novel 3D-printed customized nasal mask for improving CPAP adherence and satisfaction for the treatment of obstructive sleep apnea.

STUDY OBJECTIVES: To evaluate the performance of a novel 3D-printed customized nasal mask on patient satisfaction and compliance to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA). METHODS: Patients prescribed CPAP therapy with suboptimal CPAP compliance using a conventional CPAP mask (<70% of nights with ≥4 hours per night over 4 weeks) were recruited from the sleep investigation unit of a tertiary hospital. Patients underwent a 3D-facial mapping procedure to have a novel 3D-printed customized nasal mask fabricated which was trialed four weeks. CPAP compliance data download of the same period was conducted with their pre-existing conventional mask and customized mask. Questionnaires assessing symptoms of OSA and mask-related side-effects were administered before and after the trial of the customized mask. RESULTS: Thirty patients (twenty-two males and eight females, age 63.3 ± 12.5 years, BMI 31.7 ± 5.2 kg/m2, apnea-hypopnea index 37.3 ± 21.9 events/h [mean ± standard deviation]) were studied. CPAP was used in a greater proportion of nights with the customized mask (85.7 [66.1, 98.2]% versus 63.2 [13.1, 96.8]%, P=0.009) compared to the conventional mask. Hourly CPAP usage was higher with the customized mask (3.8 [2.7, 5.8] hours versus 2.4 [0.3, 5.0] hours, P=0.016) compared to a conventional mask. Patients preferred the customized mask (P=0.008) and reported less mask-related side effects. CONCLUSIONS: The novel 3D-printed customized mask improved CPAP usage in patients with suboptimal CPAP compliance. Customized CPAP masks may be a suitable option for patients experiencing poor CPAP compliance from mask-related side effects. CLINICAL TRIAL REGISTRATION: Registry: ANZCTR; Title: Conventional vs custom made nasal Continuous Positive Airway Pressure (CPAP) mask for treatment of Obstructive Sleep Apnoea: Pilot study A; Identifier: ACTRN12621001301853; URL: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382142.

Cardiac autonomic function in REM-related obstructive sleep apnoea: insights from nocturnal heart rate variability profiles.

PURPOSE: In light of the reported association between REM-related obstructive sleep apnoea (OSA) and heightened cardiovascular risk, this study aims to compare cardiac autonomic function in patients with REM-OSA and OSA independent of sleep stage. We hypothesized that REM-OSA patients would exhibit higher sympathetic cardiac modulation based on heart rate variability (HRV) profiles. METHODS: HRV was compared between the OSA group (AHI ≥ 5 events/h, n = 252) and the REM-OSA group (AHI ≥ 5 events/h, AHIREM:AHINREM ≥ 2, n = 137). Time- and frequency-domain measures of HRV were analysed during N2 and REM sleep. RESULTS: Clinical characteristics between the two test groups differed significantly, 45% of REM-OSA patients were female, with mild OSA (median, interquartile range (IQR)) AHI of 10 (7) events/h. Only 26% of the OSA cohort were female with moderate OSA (AHI = 17 (20) events/h, p < 0.001). Compared with the OSA group, the low frequency to high frequency ratio (LF:HF) and LF power were lower and HF power was higher in the REM-OSA group during N2 (LF:HF, p = 0.012; LF; p = 0.013; HF, p = 0.007) and in REM sleep (LF:HF, p = 0.002; LF, p = 0.004; HF, p < 0.001). Patient sex and OSA severity had a significant combined effect on average N to N interval, LF power, and LF:HF ratio during N2 and REM sleep (all p < 0.001). CONCLUSION: Contrary to our hypothesis, REM-OSA patients demonstrated consistently higher cardiac vagal modulation, reflecting better cardiac autonomic adaptation. These results were attributed to differences in OSA severity and sex in these two groups, both independently affecting HRV. This study emphasises the need for future research into the underlying pathophysiology of REM-OSA and the potential implications of sex and OSA severity on cardiovascular risk.

Device-Measured Weekend Catch-Up Sleep, Mortality, and Cardiovascular Disease Incidence in Adults.

STUDY OBJECTIVE: Attempting to recover a sleep debt by extending sleep over the weekend is a common compensatory behavior in the population and is recommended by sleep-focused organizations. However, the purported benefits of catch-up sleep are based on a limited number of cross-sectional studies that relied on self-reported sleep. The objective of this study was to examine the association between accelerometer-derived weekend catch-up sleep and mortality and incident cardiovascular disease (CVD) in adults. METHODS: A prospective cohort study of UK adults who wore wrist-attached accelerometers was conducted. Weekend catch-up sleep was defined as a longer average sleep duration on weekends compared to weekdays. Participants were categorized into four groups: no weekend catch-up sleep (reference); >0 to <1 hour; ≥1 to <2 hours; and ≥2 hours difference. Associations between weekend catch-up sleep and mortality and incident CVD were assessed using Cox proportional hazards regression, adjusted for potential confounders. RESULTS: A total of 73,513 participants (sample for mortality) and 70,518 participants (sample for CVD incidence) were included, with an average (SD) follow-up period of 8.0 (0.9) years. In multivariable-adjusted models, weekend catch-up sleep was not associated with mortality (≥2 hours group: hazard ratio [HR], 1.17 [95% CI, 0.97-1.41]) or incident CVD (HR, 1.05 [95% CI, 0.94-1.18]). Dose-response analyses treating catch-up sleep as a continuous measure or analyses restricted to adults sleeping less than 6 hours on weekdays at baseline were in agreement with these findings. CONCLUSION: Weekend catch-up sleep was not associated with mortality or CVD incidence. These findings do not align with previous evidence and recommendations by sleep authorities suggesting that extending sleep over the weekend may offer protective health benefits.

Sleep hygiene - What do we mean? A bibliographic review.

There is no consensus on the definition of sleep hygiene and its components. We examined the definition of sleep hygiene based on its use in published studies. Four databases (Medline, EMBASE, PsycINFO and CINAHL) were searched from inception until December 31, 2021 for the phrase 'sleep hygiene' in the title or abstract. We identified 548 relevant studies in adults: 250 observational and 298 intervention studies. A definition of sleep hygiene was provided in only 44% of studies and converged on three themes: behavioural factors, environmental factors, and an aspect of control. Sleep hygiene components were explicitly defined in up to 70% of observational studies, but in only 35% of intervention studies. The most commonly considered components of sleep hygiene were caffeine (in 51% of studies), alcohol (46%), exercise (46%), sleep timing (45%), light (42%), napping (39%), smoking (38%), noise (37%), temperature (34%), wind-down routine (33%), stress (32%), and stimulus control (32%), although the specific details of each component varied. Lack of consistency in definitions of sleep hygiene and its components may hinder communication between researchers, clinicians, and the public, and likely limits the utility of sleep hygiene as an intervention.

Association Between Sleep Apnea Treatment and Health Care Resource Use in Patients With Atrial Fibrillation.

BACKGROUND: Obstructive sleep apnea (OSA) contributes to the generation, recurrence, and perpetuation of atrial fibrillation, and it is associated with worse outcomes. Little is known about the economic impact of OSA therapy in atrial fibrillation. This retrospective cohort study assessed the impact of positive airway pressure (PAP) therapy adherence on health care resource use and costs in patients with OSA and atrial fibrillation. METHODS AND RESULTS: Insurance claims data for ≥1 year before sleep testing and 2 years after device setup were linked with objective PAP therapy use data. PAP adherence was defined from an extension of the US Medicare 90-day definition. Inverse probability of treatment weighting was used to create covariate-balanced PAP adherence groups to mitigate confounding. Of 5867 patients (32% women; mean age, 62.7 years), 41% were adherent, 38% were intermediate, and 21% were nonadherent. Mean±SD number of all-cause emergency department visits (0.61±1.21 versus 0.77±1.55 [P=0.023] versus 0.95±1.90 [P<0.001]), all-cause hospitalizations (0.19±0.69 versus 0.24±0.72 [P=0.002] versus 0.34±1.16 [P<0.001]), and cardiac-related hospitalizations (0.06±0.26 versus 0.09±0.41 [P=0.023] versus 0.10±0.44 [P=0.004]) were significantly lower in adherent versus intermediate and nonadherent patients, as were all-cause inpatient costs ($2200±$8054 versus $3274±$12 065 [P=0.002] versus $4483±$16 499 [P<0.001]). All-cause emergency department costs were significantly lower in adherent and intermediate versus nonadherent patients ($499±$1229 and $563±$1292 versus $691±$1652 [P<0.001 and P=0.002], respectively). CONCLUSIONS: These data suggest clinical and economic benefits of PAP therapy in patients with concomitant OSA and atrial fibrillation. This supports the value of diagnosing and managing OSA and highlights the need for strategies to enhance PAP adherence in this population.

Characterisation of Symptom and Polysomnographic Profiles Associated with Cardiovascular Risk in a Sleep Clinic Population with Obstructive Sleep Apnoea.

Aim: Recent data have identified specific symptom and polysomnographic profiles associated with cardiovascular disease (CVD) in patients with obstructive sleep apnoea (OSA). Our aim was to determine whether these profiles were present at diagnosis of OSA in patients with established CVD and in those with high cardiovascular risk. Participants in the Sydney Sleep Biobank (SSB) database, aged 30-74 years, self-reported presence of CVD (coronary artery disease, cerebrovascular disease, or heart failure). In those without established CVD, the Framingham Risk Score (FRS) estimated 10-year absolute CVD risk, categorised as "low" (<6%), "intermediate" (6-20%), or "high" (>20%). Groups were compared on symptom and polysomnographic variables. Results: 629 patients (68% male; mean age 54.3 years, SD 11.6; mean BMI 32.3 kg/m2, SD 8.2) were included. CVD was reported in 12.2%. A further 14.3% had a low risk FRS, 38.8% had an intermediate risk FRS, and 34.7% had a high risk FRS. Groups differed with respect to age, sex and BMI. OSA severity increased with established CVD and increasing FRS. The symptom of waking too early was more prevalent in the higher FRS groups (p=0.004). CVD and FRS groups differed on multiple polysomnographic variables; however, none of these differences remained significant after adjusting for age, sex, and BMI. Conclusion: Higher CVD risk was associated with waking too early in patients with OSA. Polysomnographic variations between groups were explained by demographic differences. Further work is required to explore the influence of OSA phenotypic characteristics on susceptibility to CVD.

Mandibular Advancement vs CPAP for Blood Pressure Reduction in Patients With Obstructive Sleep Apnea.

BACKGROUND: Hypertension guidelines recommend diagnosis and treatment of obstructive sleep apnea (OSA) in patients with hypertension. The mandibular advancement device (MAD) is an oral appliance therapy for patients who decline or cannot tolerate continuous positive airway pressure (CPAP). OBJECTIVES: We compared the relative effectiveness of MAD vs CPAP in reducing 24-hour ambulatory blood pressure (BP). METHODS: In an investigator-initiated, randomized, noninferiority trial (prespecified margin 1.5 mm Hg), 321 participants aged ≥40 years with hypertension and increased cardiovascular risk were recruited at 3 public hospitals for polysomnography. Of these, 220 participants with moderate-to-severe OSA (apnea-hypopnea index ≥15 events per hour) were randomized to either MAD or CPAP (1:1). The primary outcome was the difference between the 24-hour mean arterial BP at baseline and 6 months. RESULTS: Compared with baseline, the 24-hour mean arterial BP decreased by 2.5 mm Hg (P = 0.003) at 6 months in the MAD group, whereas no change was observed in the CPAP group (P = 0.374). The between-group difference was -1.6 mm Hg (95% CI: -3.51 to 0.24, noninferiority P < 0.001). The MAD group demonstrated a larger between-group reduction in all secondary ambulatory BP parameters compared with the CPAP group, with the most pronounced effects observed in the asleep BP parameters. Both the MAD and CPAP improved daytime sleepiness, with the between-group difference similar (P = 0.384). There were no between-group differences in cardiovascular biomarkers. CONCLUSIONS: MAD is noninferior to CPAP for reducing 24-hour mean arterial BP in participants with hypertension and increased cardiovascular risk. (Cardiosleep Research Program on Obstructive Sleep Apnea, Blood Pressure Control and Maladaptive Myocardial Remodeling-Non-inferiority Trial [CRESCENT]; NCT04119999).

Timing of Moderate to Vigorous Physical Activity, Mortality, Cardiovascular Disease, and Microvascular Disease in Adults With Obesity.

OBJECTIVE: To assess the association between timing of aerobic moderate to vigorous physical activity (MVPA) and risk of cardiovascular disease (CVD), microvascular disease (MVD), and all-cause mortality in adults with obesity and a subset with obesity and type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: Participants included adults with obesity (BMI ≥30 kg/m2) and a subset of those with T2D from the UK Biobank accelerometry substudy. Aerobic MVPA was defined as bouts of MVPA lasting ≥3 continuous minutes. Participants were categorized into morning, afternoon, or evening MVPA based on when they undertook the majority of their aerobic MVPA. The reference group included participants with an average of less than one aerobic MVPA bout per day. Analyses were adjusted for established and potential confounders. RESULTS: The core sample included 29,836 adults with obesity, with a mean age of 62.2 (SD 7.7) years. Over a mean follow-up period of 7.9 (SD 0.8) years, 1,425 deaths, 3,980 CVD events, and 2,162 MVD events occurred. Compared with activity in the reference group, evening MVPA was associated with the lowest risk of mortality (hazard ratio [HR] 0.39; 95% CI 0.27, 0.55), whereas afternoon (HR 0.60; 95% CI 0.51, 0.71) and morning MVPA (HR 0.67; 95% CI 0.56, 0.79) demonstrated significant but weaker associations. Similar patterns were observed for CVD and MVD incidence, with evening MVPA associated with the lowest risk of CVD (HR 0.64; 95% CI 0.54, 0.75) and MVD (HR 0.76; 95% CI 0.63, 0.92). Findings were similar in the T2D subset (n = 2,995). CONCLUSIONS: Aerobic MVPA bouts undertaken in the evening were associated with the lowest risk of mortality, CVD, and MVD. Timing of physical activity may play a role in the future of obesity and T2D management.

Heart rate variability analysis in obstructive sleep apnea patients with daytime sleepiness.

STUDY OBJECTIVES: Recent studies suggest that sleepy patients with obstructive sleep apnea (OSA) are at higher risk for incident cardiovascular disease. This study assessed cardiac autonomic function in sleepy versus non-sleepy patients with OSA using heart rate variability (HRV) analysis. We hypothesized that HRV profiles of sleepy patients would indicate higher cardiovascular risk. METHODS: Electrocardiograms (ECG) derived from polysomnograms (PSG) collected by the Sydney Sleep Biobank were used to study HRV in groups of sleepy (ESS ≥ 10) and non-sleepy OSA patients (ESS < 10). HRV parameters were averaged across available ECG signals during N2 sleep. RESULTS: A total of 421 patients were evaluated, with a mean age of 54 (14) years, body mass index of 33 (9) kg/m2, apnea-hypopnea index of 21 (28) events/h, and 66% male. The sleepy group consisted of 119 patients and the non-sleepy group 302 patients. Sleepy patients exhibited lower HRV values for: root mean square successive difference (RMSSD, p = 0.028), total power (TP, p = 0.031), absolute low frequency (LF, p = 0.045), and high-frequency (HF, p = 0.010) power compared to non-sleepy patients. Sleepy patients with moderate-to-severe OSA exhibited lower HRV values for: (RMSSD, p = 0.045; TP, p = 0.052), absolute LF (p = 0.051), and HF power (p = 0.025). There were no differences in other time and frequency domain HRV markers. CONCLUSIONS: This study shows a trend toward parasympathetic withdrawal in sleepy OSA patients, particularly in moderate-to-severe cases, lending mechanistic support to the link between the sleepy phenotype and CVD risk in OSA.

Mandibular Jaw Movement Automated Analysis for Oral Appliance Monitoring in Obstructive Sleep Apnea: A Prospective Cohort Study.

Rationale: Oral appliances are second-line treatments after continuous positive airway pressure for obstructive sleep apnea (OSA) management. However, the need for oral appliance titration limits their use as a result of monitoring challenges to assess the treatment effect on OSA. Objectives: To assess the validity of mandibular jaw movement (MJM) automated analysis compared with polysomnography (PSG) and polygraphy (PG) in evaluating the effect of oral appliance treatment and the effectiveness of MJM monitoring for oral appliance titration at home in patients with OSA. Methods: This observational, prospective study included 135 patients with OSA eligible for oral appliance therapy. The primary outcome was the apnea-hypopnea index (AHI), measured through in-laboratory PSG/PG and MJM-based technology. Additionally, MJM monitoring at home was conducted at regular intervals during the titration process. The agreement between PSG/PG and MJM automated analysis was revaluated using Bland-Altman analysis. Changes in AHI during the home-based oral appliance titration process were evaluated using a generalized linear mixed model and a generalized estimating equation model. Results: The automated MJM analysis demonstrated strong agreement with PG in assessing AHI at the end of titration, with a median bias of 0.24/h (limits of agreement, -11.2 to 12.8/h). The improvement of AHI from baseline in response to oral appliance treatment was consistent across three evaluation conditions: in-laboratory PG (-59.6%; 95% confidence interval, -59.8% to -59.5%), in-laboratory automated MJM analysis (-59.2%; -65.2% to -52.2%), and at-home automated MJM analysis (-59.7%; -67.4% to -50.2%). Conclusions: Incorporating MJM automated analysis into the oral appliance titration process has the potential to optimize oral appliance therapy outcomes for OSA.

Polysomnographic characteristics of excessive daytime sleepiness phenotypes in obstructive sleep apnea: results from the international sleep apnea global interdisciplinary consortium.

STUDY OBJECTIVES: Excessive daytime sleepiness (EDS) is a major symptom of obstructive sleep apnea (OSA). Traditional polysomnographic (PSG) measures only partially explain EDS in OSA. This study analyzed traditional and novel PSG characteristics of two different measures of EDS among patients with OSA. METHODS: Sleepiness was assessed using the Epworth Sleepiness Scale (>10 points defined as "risk of dozing") and a measure of general sleepiness (feeling sleepy ≥ 3 times/week defined as "feeling sleepy"). Four sleepiness phenotypes were identified: "non-sleepy," "risk of dozing only," "feeling sleepy only," and "both at risk of dozing and feeling sleepy." RESULTS: Altogether, 2083 patients with OSA (69% male) with an apnea-hypopnea index (AHI) ≥ 5 events/hour were studied; 46% were "non-sleepy," 26% at "risk of dozing only," 7% were "feeling sleepy only," and 21% reported both. The two phenotypes at "risk of dozing" had higher AHI, more severe hypoxemia (as measured by oxygen desaturation index, minimum and average oxygen saturation [SpO2], time spent < 90% SpO2, and hypoxic impacts) and they spent less time awake, had shorter sleep latency, and higher heart rate response to arousals than "non-sleepy" and "feeling sleepy only" phenotypes. While statistically significant, effect sizes were small. Sleep stages, frequency of arousals, wake after sleep onset and limb movement did not differ between sleepiness phenotypes after adjusting for confounders. CONCLUSIONS: In a large international group of patients with OSA, PSG characteristics were weakly associated with EDS. The physiological measures differed among individuals characterized as "risk of dozing" or "non-sleepy," while "feeling sleepy only" did not differ from "non-sleepy" individuals.

Effect of mandibular advancement splint therapy on cardiac autonomic function in obstructive sleep apnoea.

PURPOSE: This study aimed to evaluate the effect of mandibular advancement splint (MAS) therapy on cardiac autonomic function in patients with obstructive sleep apnoea (OSA) using heart rate variability (HRV) analysis. METHODS: Electrocardiograms (ECG) derived from polysomnograms (PSG) of three prospective studies were used to study HRV of patients with OSA before and after MAS treatment. HRV parameters were averaged across the entire ECG signal during N2 sleep using 2-min epochs shifted by 30 s. Paired t-tests were used to compare PSG and HRV measures before and after treatment, and the percent change in HRV measures was regressed on the percent change in apnoea-hypopnea index (AHI). RESULTS: In 101 patients with OSA, 72% were Caucasian, 54% men, the mean age was 56 ± 11 years, BMI 29.8 ± 5.3 kg/m2, and treatment duration was 4.0 ± 3.2 months. After MAS therapy, there was a significant reduction in OSA severity (AHI, - 18 ± 16 events per hour, p < 0.001) and trends towards increased low-frequency to high-frequency ratio, low-frequency power, and reduced high-frequency power (LF:HF, - 0.4 ± 1.5, p = 0.01; LF, - 3 ± 16 nu, p = 0.02, HF, 3.5 ± 13.7 nu, p = 0.01). Change in NN intervals correlated with the change in AHI (ß(SE) = - 2.21 (0.01), t = - 2.85, p = 0.005). No significant changes were observed in the time-domain HRV markers with MAS treatment. CONCLUSION: The study findings suggest that successful MAS treatment correlates with changes in HRV, specifically the lengthening of NN intervals, a marker for improved cardiac autonomic adaptability.

Standardised Tool for the Assessment of Bruxism.

OBJECTIVE: This paper aims to present and describe the Standardised Tool for the Assessment of Bruxism (STAB), an instrument that was developed to provide a multidimensional evaluation of bruxism status, comorbid conditions, aetiology and consequences. METHODS: The rationale for creating the tool and the road map that led to the selection of items included in the STAB has been discussed in previous publications. RESULTS: The tool consists of two axes, specifically dedicated to the evaluation of bruxism status and consequences (Axis A) and of bruxism risk and etiological factors and comorbid conditions (Axis B). The tool includes 14 domains, accounting for a total of 66 items. Axis A includes the self-reported information on bruxism status and possible consequences (subject-based report) together with the clinical (examiner report) and instrumental (technology report) assessment. The Subject-Based Assessment (SBA) includes domains on Sleep Bruxism (A1), Awake Bruxism (A2) and Patient's Complaints (A3), with information based on patients' self-report. The Clinically Based Assessment (CBA) includes domains on Joints and Muscles (A4), Intra- and Extra-Oral Tissues (A5) and Teeth and Restorations (A6), based on information collected by an examiner. The Instrumentally Based Assessment (IBA) includes domains on Sleep Bruxism (A7), Awake Bruxism (A8) and the use of Additional Instruments (A9), based on the information gathered with the use of technological devices. Axis B includes the self-reported information (subject-based report) on factors and conditions that may have an etiological or comorbid association with bruxism. It includes domains on Psychosocial Assessment (B1), Concurrent Sleep-related Conditions Assessment (B2), Concurrent Non-Sleep Conditions Assessment (B3), Prescribed Medications and Use of Substances Assessment (B4) and Additional Factors Assessment (B5). As a rule, whenever possible, existing instruments, either in full or partial form (i.e. specific subscales), are included. A user's guide for scoring the different items is also provided to ease administration. CONCLUSIONS: The instrument is now ready for on-field testing and further refinement. It can be anticipated that it will help in collecting data on bruxism in such a comprehensive way to have an impact on several clinical and research fields.

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.

Upper airway morphology in adults with positional obstructive sleep apnea.

PURPOSE: To compare the anatomical balance and shape of the upper airway in the supine position between adults with positional obstructive sleep apnea (POSA) and adults with non-positional OSA (NPOSA). METHODS: Adults diagnosed with OSA (apnea-hypopnea index (AHI) > 10 events/h) were assessed for eligibility. POSA was defined as the supine AHI more than twice the AHI in non-supine positions; otherwise, patients were classified as NPOSA. Cone beam computed tomography (CBCT) imaging was performed for every participant while awake in the supine position. The anatomical balance was calculated as the ratio of the tongue size to the maxillomandibular enclosure size. The upper airway shape was calculated as the ratio of the anteroposterior dimension to the lateral dimension at the location of the minimal cross-sectional area of the upper airway (CSAmin-shape). RESULTS: Of 47 participants (28 males, median age [interquartile range] 56 [46 to 63] years, median AHI 27.8 [15.0 to 33.8]), 34 participants were classified as having POSA (72%). The POSA group tended to have a higher proportion of males and a lower AHI than the NPOSA group (P = 0.07 and 0.07, respectively). After controlling for both sex and AHI, the anatomical balance and CSAmin-shape were not significantly different between both groups (P = 0.18 and 0.73, respectively). CONCLUSION: Adults with POSA and adults with NPOSA have similar anatomical balance and shape of their upper airway in the supine position. TRIAL REGISTRATION: This study was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR Trial ACTRN12611000409976).