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

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.

Figure 1. Flow chart.

A flow chart showing the number of participants at each step of the study as well as the adherence and AHI primary endpoint cohorts. AHI = apnea-hypopnea index, APAP = auto-adjusting positive airway pressure, ESS = Epworth Sleepiness Scale, OSA = obstructive sleep apnea, SPT = sleep position treatment.

Figure 2. Baseline and treatment AHI values for sleep, NREM sleep and REM sleep.

The box plot shows AHI values—median (horizontal line), interquartile range (rectangle), and the range of values excluding outlier values (whiskers) at baseline and on SPT and APAP treatment. The small black ellipses are the means. For sleep, NREM sleep, and REM sleep both treatments were significantly lower than baseline. The AHI for APAP was also lower than for SPT. The mean (SPT-APAP) AHI difference for participants was 3.58 events/h. However, the upper bound of the one sided 95% confidence interval of the mean difference was 4.96 events/h and within the prestudy noninferiority difference hypothesis of 5 events/h. AHI = apnea-hypopnea index, APAP = auto-adjusting positive airway pressure, NREM = non-rapid eye movement, REM = rapid eye movement, SPT = sleep position treatment.

Figure 3. Apnea-hypopnea index differences by severity.

The mean AHI difference between SPT and APAP treatments for mild (AHI 5 to < 15 events/h), moderate (AHI 15–30 events/h), and severe (AHI > 30 events/h) categories of severity. The error bars are the 95% confidence intervals of the means. The mean group AHI differences were not different across OSA severity (P = .4235). AHI = apneahypopnea index, APAP = auto-adjusting positive airway pressure, OSA = obstructive sleep apnea, SPT = sleep position treatment.

Figure 4. Treatment adherence.

A box plot showing median, interquartile range, and range of night adherence in minutes per night for the SPT and APAP treatments. The small black ellipses are the means. The SPT adherence (all nights) over the six-week treatment period was significantly longer than for APAP (P < .001). APAP = auto-adjusting positive airway pressure, SPT = sleep position treatment.