Atherosclerotic plaque in individuals without known cardiovascular disease but with established obstructive sleep apnea and at high risk of obstructive sleep apnea.

Objectives: In a large U.S. cohort free of CVD evaluated by coronary computed CT angiography, we aimed to assess the association between established / high risk of Obstructive Sleep Apnea (OSA) and coronary plaque. Background: There are limited data available depicting the association between established / high risk of OSA and the presence of coronary plaque in a population-based sample free from CVD. Methods: Cross-sectional data from 2359 participants enrolled in the Miami Heart Study (MiHeart) who underwent coronary CT angiography was used for this study. The Berlin questionnaire was used to stratify patients as having high or low risk of OSA. Multiple multivariable logistic regression analyses were conducted to investigate the association between the risk of developing OSA with the presence, volume, and composition of plaque. Results: According to the Berlin questionnaire, 1559 participants were (66.1%) at low risk of OSA and 800 patients (33.9%) with established / high risk of OSA. Plaque characterization on CCTA revealed a greater incidence of any possible plaque composition in the established / high risk of OSA category (59.6% vs. 43.5%) compared to the low risk of OSA cohort. In logistic regression models, after adjusting for demographics and cardiovascular risk factors, a significant association could still be noted between established / high risk of OSA and any coronary plaque on CCTA (OR=1.31, CI 1.05, 1.63, p = 0.016). Subgroup analysis in the Hispanic population also portrayed a significant association between established / high risk of OSA and the presence of coronary plaque on CCTA (OR = 1.55 CI 1.13, 2.12, p = 0.007). Conclusion: After accounting for CVD risk factors, individuals at established / high risk of OSA have a higher likelihood of the presence of coronary plaque. Future studies should focus on OSA presence or risk, OSA severity, and the longitudinal consequences of coronary atherosclerosis.

Personalized multimodal management for severe obstructive sleep apnea in a patient intolerant of positive airway pressure with hypoglossal nerve stimulator and mandibular advancement device.

Treatment of moderate to severe obstructive sleep apnea poses clinical challenges in persons with intolerance or inadequate response to traditional treatment modalities, including positive airway pressure and mandibular advancement devices. Hypoglossal nerve stimulation is a new treatment option, but few management guidelines exist when it is intolerable or ineffective. Combining several treatment modalities has been an effective strategy for improving symptoms, tolerance, and efficacy. We describe a patient intolerant to positive airway pressure therapy who had continued sleepiness, morning headaches, and snoring with a mandibular advancement device. He underwent hypoglossal nerve stimulation implantation but was intolerant of the voltages required to adequately control his obstructive sleep apnea. Multimodal management with hypoglossal nerve stimulation, mandibular advancement device, and positional therapy was successfully implemented to improve sleepiness, nocturnal symptoms, and the apnea-hypopnea index. This case highlights the personalization and adaptability of combination therapy to suit patient needs while effectively controlling obstructive sleep apnea. CITATION: Lowery MM, Rundo JV, Walia HK, Shah V. Personalized multimodal management for severe obstructive sleep apnea in a patient intolerant of positive airway pressure with hypoglossal nerve stimulator and mandibular advancement device. J Clin Sleep Med. 2023;19(2):403-408.

Association of Hypoglossal Nerve Stimulation With Improvements in Long-term, Patient-Reported Outcomes and Comparison With Positive Airway Pressure for Patients With Obstructive Sleep Apnea.

Importance: Hypoglossal nerve stimulation (HNS) and positive airway pressure (PAP) have been shown to improve patient-reported outcomes (PROs) in obstructive sleep apnea (OSA). However, to our knowledge, there are no data that compare change in PROs between HNS and PAP or that indicate whether HNS improves comorbid insomnia or depression in the long term. Objectives: To determine whether HNS is associated with improvements in patient-reported sleepiness, insomnia, and depression in the long term and to compare the respective associations of HNS and PAP with improved PROs. Design, Setting, and Participants: This retrospective cohort study used data from patients treated at the Cleveland Clinic for OSA. Participants received either HNS (referred sample) from November 1, 2015, to September 31, 2018, or PAP (previous cohort) from January 1, 2010, to December 31, 2014, for OSA. Patients were matched 3:1 for PAP:HNS based on age, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), sex, and apnea hypopnea index (AHI). Data were collected at baseline and at prespecified follow-up points. Data were analyzed from March 26, 2020, to September 9, 2021. Exposures: Treatment with HNS vs PAP. Main Outcomes and Measures: Data collected included AHI and Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Insomnia Severity Index (ISI), and Patient Health Questionnaire-9 (PHQ-9; depression) scores. Results: Among 85 patients receiving HNS (mean [SD] age, 62.8 [9.5] years; 59 men [69.4%]; 77 White patients [90.6%]; mean [SD] BMI, 28.8 [3.1]), compared with 217 matched patients receiving PAP (mean [SD] age, 62.1 [9.9] years; 157 men [72.4%]; 173 White patients [81.2%]; mean [SD] BMI, 29.5 [3.1]) included in the analysis, significant improvements were seen in PHQ-9 scores for HNS vs PAP (least square means, -4.06 [95% CI, -5.34 to -2.79] vs -2.58 [95% CI, -3.35 to -1.82]; mean difference, -1.48 [95% CI, -2.78 to -0.19]) with comparable improvements in ESS, FOSQ, and ISI scores. Clinically meaningful differences were observed in 42 of 65 HNS group patients (64.6%) vs 118 PAP group patients (54.5%) for ESS scores, 29 of 49 HNS group patients (59.2%) vs 67 of 217 PAP group patients (30.9%) for FOSQ scores, 14 of 48 HNS group patients (29.2%) vs 53 of 217 PAP group patients (24.4%) for PHQ-9 scores, and 23 of 49 HNS group patients (46.9%) vs 79 of 217 PAP group patients (36.4%) for ISI scores. At the 1-year post-HNS assessment, meaningful improvements were seen in 17 of 28 patients (60.7%) for ESS scores, 11 of 20 patients (55.0%) for FOSQ scores, 7 of 23 patients (30.4%) for PHQ-9 scores, and 11 of 25 patients (44.0%) for ISI scores. Conclusions and Relevance: In this cohort study of patients with OSA, sustained improvements in PROs were observed 1 year after HNS and were comparable to those for PAP at 3 months. These findings suggest that HNS is a viable treatment for improving insomnia and depression in patients with OSA.

Impact of Body Mass Index and Discomfort on Upper Airway Stimulation: ADHERE Registry 2020 Update.

OBJECTIVES/HYPOTHESIS: To provide the ADHERE registry Upper Airway Stimulation (UAS) outcomes update, including analyses grouped by body mass index (BMI) and therapy discomfort. STUDY DESIGN: Prospective observational study. METHODS: ADHERE captures UAS outcomes including apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), therapy usage, patient satisfaction, clinician assessment, and safety over a 1-year period. BMI ≤32 kg/m2 (BMI32 ) and 32 < BMI ≤35 kg/m2 (BMI35 ) group outcomes were examined. RESULTS: One thousand eight hundred forty-nine patients enrolled in ADHERE, 1,019 reached final visit, 843 completed the visit. Significant changes in AHI (-20.9, P < .0001) and ESS (- 4.4, P < .0001) were demonstrated. Mean therapy usage was 5.6 ± 2.2 hr/day. Significant therapy use difference was present in patients with reported discomfort versus no discomfort (4.9 ± 2.5 vs. 5.7 ± 2.1 hr/day, P = .01). Patients with discomfort had higher final visit mean AHI versus without discomfort (18.9 ± 18.5 vs. 13.5 ± 13.7 events/hr, P = .01). Changes in AHI and ESS were not significantly different. Serious adverse events reported in 2.3% of patients. Device revision rate was 1.9%. Surgical success was less likely in BMI35 versus BMI32 patients (59.8% vs. 72.2%, P = .02). There was a significant therapy use difference: 5.8 ± 2.0 hr/day in BMI32 versus 5.2 ± 2.2 hr/day in BMI35 (P = .028). CONCLUSIONS: Data from ADHERE demonstrate high efficacy rates for UAS. Although surgical response rate differs between BMI32 and BMI35 patient groups, the AHI and ESS reduction is similar. Discomfort affects therapy adherence and efficacy. Thus, proper therapy settings adjustment to ensure comfort is imperative to improve outcomes. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2616-2624, 2021.

Sleep disturbance predicts future health status after stroke.

STUDY OBJECTIVES: We evaluated factors associated with the presence of sleep disturbance in patients with stroke and whether sleep disturbance predicted change in other patient-reported domains of health over time. METHODS: Observational cohort study of 2,190 patients with stroke seen in a cerebrovascular clinic February 17, 2015 to July 5, 2017 who completed patient-reported outcome measures (PROMs) at ≥ 1 visit, including the Patient Health Questionnaire-9 depression screen, Quality of Life in Neurological Disorders (NeuroQoL) cognitive function and Patient-Reported Outcomes Information Measurement System (PROMIS) sleep disturbance, fatigue, anxiety, social role satisfaction, physical function, and pain interference. Separate multivariable models were constructed with PROMIS sleep disturbance as the dependent variable. Covariates included clinical and demographic variables, the Patient Health Questionnaire-9 depression screen scored on the PROMIS metric, and 1 of the 6 other PROMs. Among the 476 patients with ≥ 2 visits, linear regression models were constructed to determine the association of baseline sleep disturbance with follow-up PROMs after adjustment for the corresponding baseline PROMIS/NeuroQol scores, depression score, and clinical variables. RESULTS: Younger age and all PROM scores were associated with sleep disturbance; depression had the greatest association among PROMs (beta estimate 0.53, 95% confidence interval, 0.49, 0.57), physical function had the least (-0.06, 95% confidence interval, -0.11, -0.01). Baseline PROMIS sleep disturbance score was associated with worse adjusted follow-up scores for depression, fatigue, social role satisfaction, and physical function. CONCLUSIONS: Younger age and all 8 PROMs were associated with sleep disturbance in patients with stroke. The degree of sleep disturbance predicted future patient-reported outcomes for multiple domains of health. Further study is warranted to determine if interventions shown to improve sleep symptoms will also improve other outcomes.

Upper Airway Stimulation versus Untreated Comparators in Positive Airway Pressure Treatment-Refractory Obstructive Sleep Apnea.

Rationale: Understand the impact of insurance coverage on sleep apnea outcomes for patients awaiting upper airway stimulation.Objectives: Examine the natural history of impact of upper airway stimulation treatment versus insurance denial (comparators) on sleep apnea outcomes.Methods: A parallel-arm experimental study design was used to compare objective sleep apnea measures and patient-reported outcomes in those who received upper airway stimulation approval versus denial in a multinational prospective study (NCT02907398). Wilcoxon rank-sum test and logistic regression models were used to assess for differences of objective and subjective outcome changes in those who underwent upper airway stimulation versus no treatment comparators.Results: A greater reduction in apnea-hypopnea index was observed in those who underwent upper airway stimulation (n = 230, follow-up: 360 ± 171 d) versus no treatment (n = 100, follow-up: 272 ± 278 d), that is, -19.1 ± 15.8 versus -8.1 ± 20.9, respectively, P < 0.001, with consistent findings observed with nocturnal hypoxia measures. Concordantly, a greater improvement noted with subjective measures of dozing propensity was observed in patients undergoing upper airway stimulation versus comparators (Epworth Score, -5.1 ± 5.5 vs. 1.8 ± 3.7, respectively, P < 0.001) and overall sleep-related patient-reported outcomes. Women and those with previous oral appliance use had a lower odds of insurance approval (odds ratio [OR], 0.40; 95% confidence interval [95% CI], 0.22-0.71 and OR, 0.35; 95% CI, 0.18-0.69, respectively).Conclusions: Objective and subjective sleep apnea burden was more improved in those receiving upper airway stimulation versus not. Results underscore the need to optimize clinical care pathways focused on effective treatment of patients with obstructive sleep apnea who are not upper airway stimulation-insurance eligible and prioritize public health policy initiatives to address insurance-based sex-specific disparities.

Sleep-related symptoms in patients with mild stroke.

STUDY OBJECTIVES: Treatable sleep-related conditions are frequent in stroke patients, although their prevalence across stroke types and ideal method for screening is not clear. The objectives of this study were to evaluate the prevalence of sleep disturbance across different stroke types and identify approaches to the collection of sleep-related measures in clinical practice. METHODS: We performed an observational cohort study of 2,213 patients with ischemic stroke, intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), or transient ischemic attack seen in a cerebrovascular clinic February 17, 2015 through July 5, 2017 who completed at least one of the following sleep-related questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance, Insomnia Severity Index (ISI), Sleep Apnea Probability Scale (SAPS), and sleep duration. Prevalence of abnormal scores were calculated using the following thresholds: PROMIS sleep disturbance ≥ 55, ISI ≥ 15, SAPS score ≥ 0.50, and sleep duration fewer than 6 or more than 9 hours. Sensitivity, specificity, and positive and negative predictive values of PROMIS sleep disturbance T-score ≥ 55 to identify patients with moderate-severe insomnia (ISI ≥ 15) were computed. RESULTS: In the cohort, 28.6% patients (624/2183) had PROMIS sleep disturbance score ≥ 55, 17.6% (142/808) had ISI ≥ 15, and 61.3% (761/1241) had a positive SAPS screen. The frequency of abnormal sleep scale scores was similar across time periods and stroke types. The sensitivity and specificity of PROMIS sleep disturbance T-score ≥ 55 to identify patients with ISI ≥ 15 were 0.89 (95% confidence interval 0.83-0.94) and 0.81 (95% confidence interval 0.78-0.84), respectively. CONCLUSIONS: The prevalence of sleep-related symptoms in patients with mild stroke are similar across stroke types and time periods after stroke. Potential approaches to screening for sleep disturbance in stroke patients are provided.

Upper Airway Stimulation vs Positive Airway Pressure Impact on BP and Sleepiness Symptoms in OSA.

BACKGROUND: Positive airway pressure (PAP) and upper airway stimulation (UAS) are approved OSA treatment options. Although the effect of PAP on improvement in BP and daytime sleepiness (defined according to the Epworth Sleepiness Scale [ESS]) has been established, the impact of UAS on BP remains unclear. This study hypothesized that PAP and UAS will confer improvements in BP and daytime sleepiness. METHODS: Clinic-based BP and ESS scores were compared between 517 patients with OSA (apnea-hypopnea index, 15-65) and BMI ≤ 35 kg/m2 initiating PAP therapy (2010-2014) at the Cleveland Clinic and 320 patients with UAS implantation (2015-2017) via an international registry with 2- to 6-month follow-up. Mixed effect models were used to compare outcomes in 201 patients in each arm following propensity matching. RESULTS: PAP showed greater improvement in diastolic BP (mean difference of change between groups, 3.7 mm Hg; P < .001) and mean arterial pressure (mean difference of change between groups, 2.8 mm Hg; P = .008) compared with UAS. UAS showed greater improvement in ESS scores vs PAP (mean difference of change between PAP and UAS groups, -0.8; P = .046). UAS therapy usage was 6.2 h/week greater than PAP-treated patients (95% CI, 3.3-9.0). Results were consistent following adjustment for therapy adherence. CONCLUSIONS: PAP showed greater improvement in BP, potentially reflecting an enhanced ability of PAP to exert beneficial mechanical intrathoracic cardiac and vascular influences. BP measurement error in the UAS group may also have accounted for findings. Greater improvement in sleepiness symptoms was noted with UAS compared with PAP.

Impact of Positive Airway Pressure on International Restless Legs Syndrome Score in Sleep Disordered Breathing.

STUDY OBJECTIVE: Studies have shown increased prevalence of restless legs syndrome (RLS) in sleep disordered breathing (SDB), however limited data have focused on the impact of SDB therapy on RLS. We hypothesize that positive airway pressure (PAP) will improve the International Restless Legs Syndrome (IRLS) score among SDB patients compared to patients without PAP. METHODS: Patients with AHI ≥ 5 who responded positively to a RLS qualifier question from January 2010 to May 2015 were included in this retrospective study. IRLS score was used to measure RLS symptom severity. Two-sample t-tests and one-way analysis of variance were used to compare changes in IRLS score and linear regression models were created to examine IRLS change with PAP use and PAP adherence (PAP usage ≥4 h nightly for ≥70% of nights), adjusting for potential confounders. RESULTS: In 434 patients (51.9 ± 13.4years, 50.5% female, 77.6% Caucasian; 325 PAP, 109 control), IRLS scores improved from baseline to follow-up, with the PAP group achieving significant improvement after adjustment for covariates (difference in IRLS: -1.8 (CI -3.6,0.00), p = 0.050). In self-reported PAP adherent patients, IRLS improvement was greater than controls (-5.3 ± 7.4 vs. -2.7 ± 7.6 respectively, p = 0.045), and comparable to non-adherent patients (-5.3 ± 7.4 vs. -3.0 ± 7.0, p = 0.091). CONCLUSIONS: Among SDB patients with a positive RLS qualifier, those who used PAP therapy achieved significantly greater improvement in IRLS scores than patients who did not use PAP, with more significant changes in the PAP adherent group. This is the first large clinical study to examine these relationships, providing a basis for future prospective interventional trials and informing clinicians of expected improvement in IRLS score in PAP treated SDB populations.

Effect of Positive Airway Pressure Therapy on Drowsy Driving in a Large Clinic-Based Obstructive Sleep Apnea Cohort.

STUDY OBJECTIVES: Drowsy driving related to obstructive sleep apnea (OSA) represents an important public health problem with limited data on the effect of positive airway pressure (PAP) therapy. We hypothesize that PAP therapy will reduce self-reported drowsy driving in a large clinic-based OSA cohort. METHODS: Drowsy driving (self-reported near-accidents/accidents) incidents from baseline to after PAP therapy (stratified by adherence) were compared in a cohort of 2,059 patients with OSA who initiated PAP therapy from January 1, 2010 to December 31, 2014. Multivariable logistic regression models evaluated the dependence of change in drowsy driving incidents on other factors, including change in Epworth Sleepiness Scale (ESS) and Patient Health Questionnaire-9 (PHQ9) scores. RESULTS: In the entire cohort (age 56.0 ± 13.1 years, 45.4% female, 76.0% white, average follow-up 124.4 ± 67.3 days), drowsy driving incidents reduced from 14.2 to 6.9% after PAP therapy (P < .001). In subgroups, drowsy driving incidents reduced from 14% to 5.3% (P < .001) in patients who self-reported adherence to PAP therapy and 14.1% to 5.3% (P < .001) in patients objectively adherent to PAP therapy. For each one-point improvement in Epworth Sleepiness Scale score, the odds of drowsy driving decreased by about 14% (odds ratio 0.86, 95% confidence interval 0.82 to 0.90). CONCLUSIONS: In this clinic-based cohort, drowsy driving improved after adherent PAP usage, with greater drowsy driving risk for those with greater sleep propensity. This highlights the importance of and need for routine drowsy driving assessments and careful clinical attention to PAP adherence and sleep propensity in this population. Our findings should be confirmed and may be used to provide support for initiatives to address the public health issue of drowsy driving.

Beyond heart health: Consequences of obstructive sleep apnea.

Obstructive sleep apnea (OSA) is a serious condition associated with impaired quality of life, depression, drowsy driving and motor vehicle accidents, metabolic disease, and cognitive decline. The mechanisms accounting for OSA and metabolic disease include hypoxia, sleep fragmentation, and systemic inflammation. OSA appears to advance cognitive decline, and the relationship between the 2 conditions may be bidirectional. Treatment of patients with continuous positive air pressure therapy improves many of the impaired outcomes associated with OSA. Greater awareness, screening, and treatment of patients with OSA can reduce the negative consequences associated with OSA.

Practical aspects of actigraphy and approaches in clinical and research domains.

Actigraphy involves acquisition of data using a movement sensor worn continuously on the nondominant wrist, typically for a week or more. Computer-based algorithms estimate sleep episodes by analysis of continuous minutes of no to low movement, or spans of time when movement is relatively low compared with movements during presumed ambulatory wakefulness. Inherent advantages of actigraphy over polysomnography include its noninvasive nature, cost-effectiveness, lesser burden on patients/research participants, and ability to collect data over multiple days/nights, thereby allowing examination of sleep-wake patterning. Therefore, actigraphy is emerging as a common method to objectively assess sleep parameters providing estimates of sleep duration and continuity. Modes of actigraphy data collection, scoring algorithms, sleep quality/disturbance measures, validation studies, and clinical and research applications are discussed.

The Epworth Sleepiness Scale: Validation of One-Dimensional Factor Structure in a Large Clinical Sample.

STUDY OBJECTIVES: The Epworth Sleepiness Scale (ESS) is used by clinicians and researchers to determine level of daytime sleepiness. The number of factors included in the scale has been debated. Our study objective was to clarify the dimensionality of the ESS using a large clinical sample. METHODS: A retrospective cohort study included all patients presenting for care in a tertiary care sleep disorders center who answered all items on the ESS from January 8, 2008 to September 28, 2012. Dimensionality was assessed using scree plot, eigenvalues, factor loadings, principal factor analysis, and confirmatory factor analysis. Multigroup confirmatory factor analysis (MGCFA) evaluated dimensionality within 10 subgroups of clinical interest. RESULTS: The mean age of the 10,785 study participants was 50 (± 15) years with 49% female, and 81% white. The one-factor solution explained 63% of the variability in responses with high factor loadings (> .67 for all 8 items). The scree plot identified one factor with eigenvalue > 1. Results of confirmatory factor analysis demonstrated a one-factor solution had acceptable goodness of fit as assessed by root mean square error of approximation of .094 (90% confidence interval: .089-.099). MGCFA confirmed measurement invariance within all 10 demographic and clinical subgroups. CONCLUSIONS: Our study confirmed the unidimensionality of the ESS in a large diverse clinical population. Results from this study can be used to justify the interpretation of the ESS within clinical populations, and supports valid comparisons between groups based on the ESS. Future studies are warranted to further understand the items comprising the ESS and potentially eliminate redundant items for increased efficiency in clinical settings.

Evaluation of Clinical Tools to Screen and Assess for Obstructive Sleep Apnea.

ABSTRACT: Obstructive sleep apnea (OSA) is a globally recognized medical condition, associated with development of long-term adverse health consequences, including cardiovascular disease, cerebrovascular disease, neurocognitive deficiencies, and vehicular and occupational accidents. OSA can be screened effectively, because it can be identified well before the manifestation of the aforementioned poor health and public safety consequences. Additionally, appropriate management of OSA includes an assessment of outcomes before and after therapeutic intervention initiation. OSA clinical screening and outcome assessment tools exist; however, a key existing knowledge gap is identifying which tools are most clinically relevant and efficient to use in clinical practice models. The American Academy of Sleep Medicine (AASM) commissioned a task force (TF) of sleep medicine experts to identify and evaluate current OSA screening and assessment tools for adult patients and determine if they are reliable, effective, and feasible for use in clinical settings. No single tool met all the TF's objective criteria and subjective evaluation for clinical validity and feasibility to be recommended by the AASM. The TF provides several suggestions for the development of new tools or modifications to existing tools that would enhance their functionality in adults.

Depression score changes in response to sleep disordered breathing treatment with positive airway pressure in a large clinic-based cohort.

OBJECTIVE: The clinical-population impact of positive airway pressure (PAP) on depressive symptoms in sleep disordered breathing (SDB) awaits clear documentation. We hypothesized that depressive symptoms improve in response to PAP treatment in a large clinical setting, and that lower socio-economic status poses barriers to full therapeutic response. METHOD: We performed a retrospective cohort study of SDB patients attending a tertiary ambulatory sleep center between January 1, 2010 and December 31, 2015. Data extracted from electronic health records included Patient Health Questionnaire-9 (PHQ-9) scores, demographic characteristics, PAP adherence, and medical history. Paired- and two-sample t tests were utilized to assess changes in PHQ-9 score according to PAP adherence. Linear regression models were constructed to evaluate the association of socioeconomic status (SES) and other clinical variables on PHQ-9 scores. RESULTS: The cohort consisted of 1981 SDB patients (56.4 ± 13.3 years; 45.7% female; 76.2% Caucasian). Regardless of adherence, PAP therapy improved PHQ-9 scores (- 2.4 ± 4.6, p < 0.0001), with more robust responses in patients with baseline PHQ-9 scores > 10 (- 4.8 ± 5.7; p < 0.0001). Adherent patients had significantly greater improvement (- 2.8 ± 4.4 vs. 1.6 + 4.2, p < 0.0001), and even greater benefit if baseline PHQ-9 was > 10 (-6.0 ± 5.3 vs. - 3.8 ± 4.9, p < 0.001). Patients from lower socioeconomic status and greater depressive symptom had worse post-PAP PHQ-9 scores. CONCLUSIONS: PAP therapy and adherence were associated with improvement in depressive symptom severity in this clinical cohort. Patients with lower socioeconomic status derived less therapeutic benefit, suggesting that they faced additional barriers to treatment effectiveness.

Impact of Sleep-Disordered Breathing Treatment on Quality of Life Measures in a Large Clinic-Based Cohort.

STUDY OBJECTIVES: This study aims to report the effect of positive airway pressure (PAP) therapy on quality of life (QoL) measures in the clinical sleep-disordered breathing (SDB) population. METHODS: We examined general QoL measures assessed by European Quality of Life-5D (EQ-5D) and sleep-specific QoL by examining Functional Outcomes of Sleep Questionnaire (FOSQ) scores before and after PAP therapy retrospectively in a clinical SDB population using paired and two-sample t tests. Age and socioeconomic status (SES) effect modification on pre-PAP QoL measures were investigated utilizing the interaction terms. RESULTS: A total of 2,027 patients with SDB initiated PAP therapy between January 1, 2010 and December 31, 2014. The mean age of the cohort was 56.2 years (standard deviation = 13.2), with 45.8% female and 76.9% Caucasians. EQ-5D change after exclusion of those with normal QoL was 0.042 (0.152) in all patients, 0.051 (0.150) in patients who were PAP adherent by self-report, and 0.050 (0.132) in patients who were objectively PAP adherent (n = 704 of 1,011 with available objective adherence data, 69.6%). Change in FOSQ after excluding those with normal FOSQ was 1.9 (2.9) in all patients, 2.2 (2.9) in patients who were PAP adherent by self-report, and 2.3 (2.9) in patients who were objectively PAP adherent. Those with (1) worse QoL at baseline and younger age and (2) worse QoL at baseline and residing in lower SES strata had worse outcomes after PAP therapy (P < .05). CONCLUSIONS: We found consistent improvement in global and sleep-specific QoL measures after PAP therapy, hence providing evidence of PAP benefit in the clinical population and rationale for targeted efforts to optimize QoL in younger and lower SES subgroups.

Impact of Sleep-Disordered Breathing Treatment on Patient Reported Outcomes in a Clinic-Based Cohort of Hypertensive Patients.

STUDY OBJECTIVES: We hypothesized that patient reported outcomes (PROs) improve with positive airway pressure (PAP) in patients with sleep-disordered breathing (SDB) and hypertension (HTN). METHODS: Questionnaire-based PROs (sleepiness [Epworth Sleepiness Scale, (ESS)], depression [Patient Health Questionnaire-9 (PHQ-9)], and fatigue [Fatigue Severity Scale (FSS)]) were retrospectively examined in patients with SDB and HTN at baseline and within a year following PAP initiation. PRO changes were estimated using multivariable linear mixed-effect models adjusted for baseline age, sex, race, body mass index, resistant hypertension (RHTN) status, cardiac and diabetes history, and correlation between repeated measurements. Age and race by PAP interaction terms (mean change, 95% CI) were examined. RESULTS: 894 patients with HTN and SDB were examined. 130 (15%) had baseline RHTN (age 58 ± 12 y, 52.9 % male, BMI 36.2 ± 9.1 kg/m2). In multivariable models, a significant improvement in sleepiness ESS (-2.09, 95% CI: -2.37, -1.82), PHQ-9 (-1.91, 95% CI: -2.25, -1.56), and FSS scores (-4.06 95% CI: -4.89, -3.22) was observed. A significant race by PAP effect interaction was observed (p < 0.0001 for all PROs); Caucasians had greater improvements than non-Caucasians. The interaction term of effect of PAP and age was significant for ESS (p = 0.04) and PHQ-9 (p = 0.0003), indicating greater improvement in younger patients. CONCLUSIONS: Consistent improvement of broad PRO domains in response to PAP in SDB was observed in this clinic-based hypertensive cohort; Caucasians and younger patients derived greater benefit.