Dataset Information

Effect of Continuous Positive Airway Pressure Treatment on Health-Related Quality of Life and Sleepiness in High Cardiovascular Risk Individuals With Sleep Apnea: Best Apnea Interventions for Research (BestAIR) Trial.

ABSTRACT:

Study objectives

The long-term effect of continuous positive airway pressure (CPAP) on health-related quality of life (HRQOL) in patients with high cardiovascular disease risk and obstructive sleep apnea (OSA) without severe sleepiness is uncertain. We aimed to determine the effect of CPAP treatment on HRQOL in individuals with moderate or severe OSA and cardiovascular disease (CVD) or multiple CVD risk factors without severe sleepiness.

Methods

In this randomized, controlled, parallel group study, 169 participants were assigned to treatment with CPAP or the control group (conservative medical therapy [CMT] or CMT with sham CPAP). Analyses were based on an intention-to-treat approach. Linear mixed effect models were fitted to compare the changes in the Medical Outcomes Study Short Form-36 (SF-36) and in subjective sleepiness (Epworth Sleepiness Scale [ESS]) between groups from baseline to the average of 6- and 12-month measurements.

Results

CPAP improved several domains of HRQOL including bodily pain (treatment effect 9.7 [95% confidence interval, CI 3.9 to 15.4]; p = .001), vitality (5.7 [95% CI 1.5 to 9.9]; p = .008), general health (8.2 [95% CI 3.7 to 12.7]; p < .001), physical functioning (5.5 [95% CI 1.1 to 10.0]; p = .016), and the physical health summary score (3.3 [95% CI 1.4 to 5.3]; p = .001). CPAP also resulted in less daytime sleepiness (mean change in ESS -1.0 point [95% CI -2.0 to -0.0]; p = .040).

Conclusions

In patients with moderate-severe OSA at high risk of cardiovascular events and without severe sleepiness, CPAP improved daytime sleepiness and multiple domains of HRQOL over 6 to 12 months of follow-up, with the largest improvement observed for bodily pain.

SUBMITTER: Zhao YY

PROVIDER: S-EPMC5806548 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Publications

Effect of Continuous Positive Airway Pressure Treatment on Health-Related Quality of Life and Sleepiness in High Cardiovascular Risk Individuals With Sleep Apnea: Best Apnea Interventions for Research (BestAIR) Trial.

Zhao Ying Y YY Wang Rui R Gleason Kevin J KJ Lewis Eldrin F EF Quan Stuart F SF Toth Claudia M CM Morrical Michael M Rueschman Michael M Weng Jia J Ware James H JH Mittleman Murray A MA Redline Susan S

Sleep 20170401 4

<h4>Study objectives</h4>The long-term effect of continuous positive airway pressure (CPAP) on health-related quality of life (HRQOL) in patients with high cardiovascular disease risk and obstructive sleep apnea (OSA) without severe sleepiness is uncertain. We aimed to determine the effect of CPAP treatment on HRQOL in individuals with moderate or severe OSA and cardiovascular disease (CVD) or multiple CVD risk factors without severe sleepiness.<h4>Methods</h4>In this randomized, controlled, par ...[more]

PMID: 28419387

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Project description:Excessive daytime sleepiness (EDS) is a symptom of obstructive sleep apnea (OSA) that resolves under treatment with continuous positive airway pressure (CPAP). In some patients, sleepiness persists despite CPAP treatment. We retrospectively analyzed data on subjective residual EDS, assessed as an Epworth Sleepiness Scale score (ESS) >10, in patients from the European Sleep Apnea Database (n = 4,853, mean age ± SD 54.8 ± 11.8 years, 26.1% females), at baseline and at the first visit (median follow-up: 5 months, interquartile range 3-13). An ESS > 10 occurred in 56% of patients at baseline and in 28.2% of patients at follow-up. Residual EDS was analyzed in 2,190 patients (age: 55.1 ± 12.0 years, 26.1% females) with sleep monitoring data (median follow-up: 3 months, interquartile range 1-15). Sleep studies during CPAP use were obtained in 58% of these patients; EDS was reported by 47.2% of patients at baseline and by 30.3% at follow-up. Residual OSA, defined as an apnea-hypopnea index >10/h, and insufficient CPAP adherence, defined as nightly use <4 h, occurred with similar frequency in patients with and without EDS at follow-up. Prevalence of residual EDS was highest (40%) in patients with a first follow-up visit at 0-3 months, then it was 13-19% in patients with a first follow-up visit after 4 months to 2 years. The change in ESS (n = 2,190) was weakly correlated with CPAP use (R2 = 0.023, p < 0.0001). Logistic regression showed that an ESS score >10 at the first follow-up visit was associated directly with ESS at baseline and inversely with duration of follow-up, and CPAP use (R2 of the model: 0.417). EDS showed heterogeneity in different European countries both at baseline and at the first follow-up visit, suggesting modulation by cultural and lifestyle factors. In conclusion, residual EDS in CPAP-treated OSA occurred in approximately one in four patients at follow-up; its prevalence was highest (40%) in the first 3 months of treatment and subsequently decreased. The finding of residual EDS in a significant percentage of optimally treated OSA patients suggests that wake-promoting agents may be useful, but their indication should be evaluated after at least 3 months of treatment.

Project description:Rationale: Excessive daytime sleepiness is a common disabling symptom in obstructive sleep apnea syndrome.Objectives: To evaluate the efficacy and safety of pitolisant, a selective histamine H3 receptor antagonist with wake-promoting effects, for the treatment of daytime sleepiness in patients with moderate to severe obstructive sleep apnea refusing continuous positive airway pressure treatment.Methods: In an international, multicenter, double-blind, randomized (3:1), placebo-controlled, parallel-design trial, pitolisant was individually titrated at up to 20 mg/d over 12 weeks. The primary endpoint was the change in the Epworth Sleepiness Scale score. Key secondary endpoints were maintenance of wakefulness assessed on the basis of the Oxford Sleep Resistance test, safety, Clinical Global Impression of severity, patient's global opinion, EuroQol quality-of-life questionnaire, and Pichot fatigue questionnaire.Measurements and Main Results: A total of 268 patients with obstructive sleep apnea (75% male; mean age, 52 yr; apnea-hypopnea index, 49/h; baseline sleepiness score, 15.7) were randomized (200 to pitolisant and 68 to placebo) and analyzed on an intention-to-treat basis. The Epworth Sleepiness Scale score was reduced more with pitolisant than with placebo (-2.8; 95% confidence interval, -4.0 to -1.5; P < 0.001). Wake maintenance tests were not improved. The Pichot fatigue score was reduced with pitolisant. The overall impact of pitolisant was confirmed by both physicians' and patients' questionnaires. Adverse event incidence, mainly headache, insomnia, nausea, and vertigo, was similar in the pitolisant and placebo groups (29.5% and 25.4%, respectively), with no cardiovascular or other significant safety concerns.Conclusions: Pitolisant significantly reduced self-reported daytime sleepiness and fatigue and improved patient-reported outcomes and physician disease severity assessment in sleepy patients with obstructive sleep apnea refusing or nonadherent to continuous positive airway pressure.Clinical trial registered with www.clinicaltrials.gov (NCT01072968) and EU Clinical Trials Register (EudraCT 2009-017251-94).

Project description:Background Studies have shown that a significant percentage of patients with obstructive sleep apnea (OSA) do not tolerate continuous positive airway pressure (CPAP) therapy and long-term use may be as low as 30%. Given the lower levels of symptoms and health-related risks, patients with mild sleep apnea may be at even higher risk for non-adherence to long term CPAP. The purpose of our study was to investigate the prevalence and associations of long-term CPAP adherence in first time users with mild sleep apnea diagnosed by home sleep apnea testing (HSAT). Methods We identified all the patients who were diagnosed with mild sleep apnea (5 = < AHI < 15) by home sleep apnea testing from 01/2013 to 06/2019 at a large, combined community and hospital-based sleep practice. Only first time CPAP users were included. Compliance was defined as CPAP usage ≥ 4 h per night on ≥ 70% of nights over 30 consecutive days. We defined long term adherence as compliance on the 12th month following CPAP set up. Patient demographics, comorbidities, and CPAP compliance at 1st, 3rd, 6th, 9th and 12th month after therapy initiation were collected. We compared and identified the factors that had significant difference (P < 0.1) between compliant and non-compliant groups at the 12th month. Results 222 patients were included in the analysis. 57 (25.7%) patients were adherent with long term CPAP treatment. The following factors were associated with a greater likelihood for long-term CPAP adherence: older age, lower body mass index (BMI), presence of a bed partner, non-smoker, presence of Diabetes Mellitus (DM), presence of Heart Failure (CHF), lack of depression, and compliance at 1st, 3rd, 6th and 9th month. Conclusions Long term CPAP compliance in mild sleep apnea patients is low. Long term adherence to CPAP can be predicted based on CPAP adherence during the first three months. Supplementary Information The online version contains supplementary material available at 10.1186/s12890-023-02612-3.

Project description:Study objectiveTo determine the neurocognitive effects of continuous positive airway pressure (CPAP) therapy on patients with obstructive sleep apnea (OSA).Design, setting, and participantsThe Apnea Positive Pressure Long-term Efficacy Study (APPLES) was a 6-month, randomized, double-blind, 2-arm, sham-controlled, multicenter trial conducted at 5 U.S. university, hospital, or private practices. Of 1,516 participants enrolled, 1,105 were randomized, and 1,098 participants diagnosed with OSA contributed to the analysis of the primary outcome measures.InterventionActive or sham CPAP MEASUREMENTS: THREE NEUROCOGNITIVE VARIABLES, EACH REPRESENTING A NEUROCOGNITIVE DOMAIN: Pathfinder Number Test-Total Time (attention and psychomotor function [A/P]), Buschke Selective Reminding Test-Sum Recall (learning and memory [L/M]), and Sustained Working Memory Test-Overall Mid-Day Score (executive and frontal-lobe function [E/F])ResultsThe primary neurocognitive analyses showed a difference between groups for only the E/F variable at the 2 month CPAP visit, but no difference at the 6 month CPAP visit or for the A/P or L/M variables at either the 2 or 6 month visits. When stratified by measures of OSA severity (AHI or oxygen saturation parameters), the primary E/F variable and one secondary E/F neurocognitive variable revealed transient differences between study arms for those with the most severe OSA. Participants in the active CPAP group had a significantly greater ability to remain awake whether measured subjectively by the Epworth Sleepiness Scale or objectively by the maintenance of wakefulness test.ConclusionsCPAP treatment improved both subjectively and objectively measured sleepiness, especially in individuals with severe OSA (AHI > 30). CPAP use resulted in mild, transient improvement in the most sensitive measures of executive and frontal-lobe function for those with severe disease, which suggests the existence of a complex OSA-neurocognitive relationship.Clinical trial informationRegistered at clinicaltrials.gov. Identifier: NCT00051363.CitationKushida CA; Nichols DA; Holmes TH; Quan SF; Walsh JK; Gottlieb DJ; Simon RD; Guilleminault C; White DP; Goodwin JL; Schweitzer PK; Leary EB; Hyde PR; Hirshkowitz M; Green S; McEvoy LK; Chan C; Gevins A; Kay GG; Bloch DA; Crabtree T; Demen WC. Effects of continuous positive airway pressure on neurocognitive function in obstructive sleep apnea patients: the Apnea Positive Pressure Long-term Efficacy Study (APPLES). SLEEP 2012;35(12):1593-1602.

Dataset Information

Effect of Continuous Positive Airway Pressure Treatment on Health-Related Quality of Life and Sleepiness in High Cardiovascular Risk Individuals With Sleep Apnea: Best Apnea Interventions for Research (BestAIR) Trial.

Study objectives

Methods

Results

Conclusions

Publications

Effect of Continuous Positive Airway Pressure Treatment on Health-Related Quality of Life and Sleepiness in High Cardiovascular Risk Individuals With Sleep Apnea: Best Apnea Interventions for Research (BestAIR) Trial.

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