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Randomized Controlled Trial
. 2022 Apr 1;18(4):1027-1034.
doi: 10.5664/jcsm.9792.

Dose-response relationship between positive airway pressure therapy and excessive daytime sleepiness: the HomePAP study

Maeve Pascoe  1 , James Bena  1 , Noah D Andrews  1 , Dennis Auckley  2 , Ruth Benca  3 , Martha E Billings  4 , Vishesh K Kapur  4 , Conrad Iber  5 , Phyllis C Zee  6 , Susan Redline  7 , Carol L Rosen  8 , Nancy Foldvary-Schaefer  1
Affiliations
Randomized Controlled Trial

Dose-response relationship between positive airway pressure therapy and excessive daytime sleepiness: the HomePAP study

Maeve Pascoe et al. J Clin Sleep Med. .

Abstract

Study objectives: The clinical benefits of positive airway pressure (PAP) therapy for obstructive sleep apnea are assumed to require adherent PAP usage, defined by the Centers for Medicare & Medicaid Services as ≥ 4 hours of use ≥ 70% of nights. However, this definition is based on early data and does not necessarily capture improvements at subthreshold adherence. We explored dose-response relationships between PAP adherence measures and excessive daytime sleepiness from the HomePAP randomized controlled trial.

Methods: Participants aged ≥ 18 years with an apnea-hypopnea index ≥ 15 events/h and baseline sleepiness (Epworth Sleepiness Scale [ESS] ≥ 12) received PAP therapy. Data were collected at baseline, 1-month follow-up, and 3-months follow-up. Regression models and receiver operating characteristic curves evaluated PAP measures as predictors of ESS change and normalization (ESS < 10).

Results: In 119 participants (aged 49.4 ± 12.6 years, 66.4% male, 72.3% White), > 50% were PAP nonadherent per Centers for Medicare & Medicaid Services criteria at 3 months. The percentage of nights with PAP use ≥ 4 hours predicted ESS change (P = .023), but not when controlling for the apnea-hypopnea index. The percentage of nights with ≥ 4 hours and average PAP use provided the best discrimination for predicting ESS normalization; each 10% increase in PAP use ≥ 4 hours increased the odds of ESS normalization by 22% (P = .007); those using PAP ≥ 4 hours had a nearly 3-fold greater odds of ESS normalization (P = .025). PAP use for at least 4 hours and on 70% of nights provided the best balance between specificity (0.50) and sensitivity (0.73).

Conclusions: Although subadherent PAP usage may still confer some benefit for patients with obstructive sleep apnea, adherence to current criteria confers the highest likelihood for ESS change and normalization.

Clinical trial registration: Registry: ClinicalTrials.gov; Name: Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP); URL: https://clinicaltrials.gov/ct2/show/NCT00642486; Identifier: NCT00642486.

Citation: Pascoe M, Bena J, Andrews ND, et al. Dose-response relationship between positive airway pressure therapy and excessive daytime sleepiness: the HomePAP study. J Clin Sleep Med. 2022;18(4):1027-1034.

Keywords: Epworth Sleepiness Scale; HomePAP trial; PAP therapy; adherence; excessive daytime sleepiness.

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Conflict of interest statement

All authors have seen and approved the manuscript. All work for this study was performed at the institutions listed: University Hospitals, MetroHealth Medical Center, and Cleveland Clinic, Cleveland, OH; Northwestern University, Chicago, IL; University of Wisconsin, Madison, WI; University of Minnesota, Minneapolis, MN; and University of Washington, Seattle, WA. Dr. Benca has served as a consultant to Eisai, Genomind, Idorsia, Jazz, Merck, and Sunovion. Dr. Foldvary-Schaefer has research funding from Jazz (unrelated to study), Takeda, and Suven. Dr. Iber has research funding from Inspire Medical. Drs. Kapur and Rosen were board members of the American Academy of Sleep Medicine at the time of submission of this article. They contributed to this article in their personal capacity. The views expressed are their own and do not necessarily represent the views of the American Academy of Sleep Medicine. Dr. Redline has received consulting fees from ApniMed Inc., Lily Inc., Eisai Inc., and Jazz (unrelated to the study) and grants from the National Institutes of Health and Jazz. Dr. Zee has received grants from the National Institutes of Health, Vanda, and Philips Respironics. Maeve Pascoe, Noah Andrews, James Bena, Dr. Auckley and Dr. Billings report no conflicts of interest.

Figures

Figure 1
Figure 1. Forest plot of change in ESS at 3 months by PAP adherence criteria, adjusting for baseline ESS, race, depression, randomized group, and income.
The mean ESS changes stratified by PAP adherence criteria. CI = confidence interval, ESS = Epworth Sleepiness Scale, PAP = positive airway pressure.
Figure 2
Figure 2. Forest plot of odds ratios for ESS normalization at 3 months by PAP adherence criteria, adjusting for baseline ESS.
Odds ratios for ESS normalization stratified by PAP adherence criteria. CI = confidence interval, ESS = Epworth Sleepiness Scale, PAP = positive airway pressure.
Figure 3
Figure 3. ROC curves for prediction of ≥ 2-point ESS change at 3 months.
ROC curves for prediction of ≥ 2-point ESS change using 3 PAP adherence criteria. AUCs were 0.60 (95% CI, 0.44–0.75) for “Average Use” (average PAP use), 0.62 (95% CI, 0.46–0.77) for “% Nights PAP ≥ 4 hours” (percentage of nights with PAP use ≥ 4 hours), and 0.53 (95% CI, 0.31–0.75) for “% Sleep Hours w/PAP” (percentage of sleep hours with PAP use per night). Points highlighted reflect the largest combination of sensitivity and specificity (Youden Index). AUC = area under the curve, CI = confidence interval, ESS = Epworth Sleepiness Scale, PAP = positive airway pressure, ROC = receiver operating characteristic.
Figure 4
Figure 4. ROC curves for prediction of ESS normalization at 3 months.
Shown are ROC curves for prediction of ESS normalization using 3 PAP adherence criteria. AUCs were 0.68 (95% CI, 0.56–0.79) for “Average Use” (average PAP use), 0.71 (95% CI, 0.59–0.82) for “% Nights PAP ≥ 4 hours” (percentage of nights with PAP use ≥ 4 hours), and 0.60 (95% CI, 0.44–0.75) for “% Sleep Hours w/PAP” (percentage of sleep hours with PAP use per night). Points highlighted reflect the largest combination of sensitivity and specificity (Youden Index). AUC = area under the curve, CI = confidence interval, ESS = Epworth Sleepiness Scale, PAP = positive airway pressure, ROC = receiver operating characteristic curve.
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