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Volume 15 No. 07
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Accepted Papers





Scientific Investigations

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

Richard B. Berry, MD1; Matthew L. Uhles, RPSGT2; Brian K. Abaluck, MD3; David H. Winslow, MD4; Paula K. Schweitzer, PhD5; Raymond A. Gaskins, MD6; Robert C. Doekel, MD7; Helene A. Emsellem, MD8
1University of Florida, Gainesville, Florida; 2Clayton Sleep Institute, Maplewood, Missouri; 3Paoli Hospital Sleep Center, Paoli, Pennsylvania; 4Norton Clinical Research Group, Louisville, Kentucky; 5St. Luke's Hospital, Chesterfield, Missouri; 6Med One Sleep, Fayetteville, North Carolina; 7Sleep Disorders Center of Alabama, Birmingham, Alabama; 8The Center for Sleep and Wake Disorders, Chevy Chase, Maryland

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

Citation:

Berry RB, Uhles ML, Abaluck BK, Winslow DH, Schweitzer PK, Gaskins RA Jr, Doekel RC Jr, Emsellem HA. NightBalance sleep position treatment device versus auto-adjusting positive airway pressure for treatment of positional obstructive sleep apnea. J Clin Sleep Med. 2019;15(7):947–956.


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