NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea

Richard B Berry; Matthew L Uhles; Brian K Abaluck; David H Winslow; Paula K Schweitzer; Raymond A Gaskins Jr; Robert C Doekel Jr; Helene A Emsellem

doi:10.5664/jcsm.7868

NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea

J Clin Sleep Med. 2019 Jul 15;15(7):947-956. doi: 10.5664/jcsm.7868.

Authors

Richard B Berry¹, Matthew L Uhles², Brian K Abaluck³, David H Winslow⁴, Paula K Schweitzer⁵, Raymond A Gaskins Jr⁶, Robert C Doekel Jr⁷, Helene A Emsellem⁸

Affiliations

¹ University of Florida, Gainesville, Florida.
² Clayton Sleep Institute, Maplewood, Missouri.
³ Paoli Hospital Sleep Center, Paoli, Pennsylvania.
⁴ Norton Clinical Research Group, Louisville, Kentucky.
⁵ St. Luke's Hospital, Chesterfield, Missouri.
⁶ Med One Sleep, Fayetteville, North Carolina.
⁷ Sleep Disorders Center of Alabama, Birmingham, Alabama.
⁸ The Center for Sleep and Wake Disorders, Chevy Chase, Maryland.

Abstract

Study objectives: Compare treatment efficacy and objective adherence between the NightBalance sleep position treatment (SPT) device and auto-adjusting positive airway pressure (APAP) in patients with exclusive positional obstructive sleep apnea (ePOSA) defined as a supine apnea-hypopnea index (sAHI) ≥ 2 times the nonsupine AHI (nsAHI) and a nsAHI < 10 events/h.

Methods: This prospective multicenter randomized crossover trial enrolled treatment naive participants with ePOSA (AHI ≥ 15 events/h and nsAHI < 10 events/h) or (AHI > 10 and < 15 events/h with daytime sleepiness and nsAH < 5 events/h). Polysomnography and objective adherence determination (device data) were performed at the end of each 6-week treatment. Patient device preference was determined at the end of the study.

Results: A total of 117 participants were randomized (58 SPT first, 59 APAP first). Of these, 112 started treatment with the second device (adherence cohort) and 110 completed the study (AHI cohort). The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h, P < .001). The mean AHI difference (SPT-APAP) was 3.58 events/h with a one sided 95% confidence interval upper bound of 4.96 events/h (< the prestudy noninferiority margin of 5 events/h). The average nightly adherence (all nights) was greater on SPT (345.3 ± 111.22 versus 286.98 ± 128.9 minutes, P < .0001). Participants found the SPT to be more comfortable and easier to use and 53% reported a preference for SPT assuming both devices were equally effective.

Conclusions: Treatment with SPT resulted in non-inferior treatment efficacy and greater adherence compared to APAP in ePOSA suggesting that SPT is an effective treatment for this group.

Clinical trial registration: Registry: ClinicalTrials.gov; Title: The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea; Identifier: NCT03061071; URL: https://clinicaltrials.gov/ct2/show/NCT03061071.

Keywords: continuous positive airway pressure; obstructive sleep apnea; position treatment.

Publication types

Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Cohort Studies
Continuous Positive Airway Pressure / methods*
Cross-Over Studies
Female
Humans
Male
Middle Aged
Patient Compliance / statistics & numerical data*
Patient Positioning / instrumentation*
Patient Positioning / methods
Patient Preference / statistics & numerical data*
Polysomnography
Posture*
Prospective Studies
Sleep Apnea, Obstructive / therapy*
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03061071