Jessie P Bakker1, Rui Wang2, Jia Weng3, Mark S Aloia4, Claudia Toth3, Michael G Morrical3, Kevin J Gleason3, Michael Rueschman3, Cynthia Dorsey5, Sanjay R Patel3, James H Ware6, Murray A Mittleman7, Susan Redline3. 1. Division of Sleep & Circadian Disorders, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address: jpbakker@bwh.harvard.edu. 2. Division of Sleep & Circadian Disorders, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA. 3. Division of Sleep & Circadian Disorders, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. 4. National Jewish Health, Denver, CO; Philips Respironics, Murrysville, PA. 5. McLean Hospital, Harvard Medical School, Boston, MA. 6. Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA. 7. Department of Epidemiology, Harvard TH Chan School of Public Health and Cardiovascular Epidemiology Research Unit, Beth Israel Deaconess Medical Center, Boston, MA.
Abstract
BACKGROUND:Motivational enhancement (ME) shows promise as a means of increasing adherence to CPAP for OSA. METHODS: We performed an open-label, parallel-arm, randomized controlled trial of CPAP only or CPAP + ME, recruiting individuals 45 to 75 years with moderate or severe OSA without marked sleepiness and with either established cardiovascular disease (CVD) or at risk for CVD. All participants received standardized CPAP support from a sleep technologist; those randomly assigned to CPAP + ME also received standardized ME delivered by a psychologist during two appointments and six phone calls over 32 weeks. Mixed-effect models with subject-specific intercepts and slopes were fitted to compare objective CPAP adherence between arms, adjusting for follow-up duration, randomization factors, and device manufacturer. All analyses were intention-to-treat. RESULTS: Overall, 83 participants (n = 42 CPAP only; n = 41 CPAP + ME) contributed 14,273 nights of data for 6 months. Participants were predominantly male (67%) and had a mean ±SD age of 63.9 ± 7.4 years, a BMI of 31.1 ± 5.2 kg/m(2), and an apnea-hypopnea index of 26.2 ± 12.9 events/h. In our fully adjusted model, average nightly adherence for 6 months was 99.0 min/night higher with CPAP + ME compared with CPAP only (P = .003; primary analysis). A subset of 52 participants remained in the study for 12 months; modeling these data yielded a consistent difference in adherence between arms of 97 min/night (P = .006) favoring CPAP + ME. CONCLUSIONS: ME delivered during brief appointments and phone calls resulted in a clinically significant increase in CPAP adherence. This strategy may represent a feasible approach for optimizing management of OSA. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01261390; URL: www.clinicaltrials.gov.
RCT Entities:
BACKGROUND: Motivational enhancement (ME) shows promise as a means of increasing adherence to CPAP for OSA. METHODS: We performed an open-label, parallel-arm, randomized controlled trial of CPAP only or CPAP + ME, recruiting individuals 45 to 75 years with moderate or severe OSA without marked sleepiness and with either established cardiovascular disease (CVD) or at risk for CVD. All participants received standardized CPAP support from a sleep technologist; those randomly assigned to CPAP + ME also received standardized ME delivered by a psychologist during two appointments and six phone calls over 32 weeks. Mixed-effect models with subject-specific intercepts and slopes were fitted to compare objective CPAP adherence between arms, adjusting for follow-up duration, randomization factors, and device manufacturer. All analyses were intention-to-treat. RESULTS: Overall, 83 participants (n = 42 CPAP only; n = 41 CPAP + ME) contributed 14,273 nights of data for 6 months. Participants were predominantly male (67%) and had a mean ± SD age of 63.9 ± 7.4 years, a BMI of 31.1 ± 5.2 kg/m(2), and an apnea-hypopnea index of 26.2 ± 12.9 events/h. In our fully adjusted model, average nightly adherence for 6 months was 99.0 min/night higher with CPAP + ME compared with CPAP only (P = .003; primary analysis). A subset of 52 participants remained in the study for 12 months; modeling these data yielded a consistent difference in adherence between arms of 97 min/night (P = .006) favoring CPAP + ME. CONCLUSIONS:ME delivered during brief appointments and phone calls resulted in a clinically significant increase in CPAP adherence. This strategy may represent a feasible approach for optimizing management of OSA. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01261390; URL: www.clinicaltrials.gov.
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