Dataset Information

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.

SUBMITTER: Berry RB

PROVIDER: S-EPMC6622520 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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

Berry Richard B RB Uhles Matthew L ML Abaluck Brian K BK Winslow David H DH Schweitzer Paula K PK Gaskins Raymond A RA Doekel Robert C RC Emsellem Helene A HA

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine 20190715 7

<h4>Study objectives</h4>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.<h4>Methods</h4>This prospective multicenter randomized crossover trial enrolled treatment naive participants with ePOSA (AHI ≥ 15 ...[more]

PMID: 31383231

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Project description:Study objectivesUpper airway stimulation (UAS) is an alternative treatment for obstructive sleep apnea that must be activated nightly. Although the implanted device offsets the mask- or pressure-related side effects often associated with continuous positive airway pressure therapy, some UAS recipients do not use the therapy consistently. This study qualitatively explored factors associated with UAS usage in obstructive sleep apnea patients.MethodsSemistructured interviews were conducted with 24 obstructive sleep apnea patients who received UAS treatment. Twelve patients were categorized as high users with mean usage of ≥ 4 hours/night and 12 were categorized as low users with < 4 hours/night or nonuse. Interviews explored patients' experiences regarding barriers and facilitators to UAS use and their advice for new UAS recipients. Demographic and clinical data including the Insomnia Severity Index and Generalized Anxiety Disorder Scale were collected.ResultsCompared to high users, low users had higher levels of insomnia (mean Insomnia Severity Index: 3.6 vs 15.2, respectively) and anxiety (mean Generalized Anxiety Disorder Scale: 3.4 vs 6.9). High users reported more positive experiences with UAS treatment, such as improvements in symptoms and convenience of treatment, as facilitators of use. Low users tended to focus on the negative aspects of treatment, particularly stimulation-related discomfort and associated sleep disturbance.ConclusionsInsomnia with or without anxiety contributes to differing patient-reported experiences in high vs low user groups, with increased insomnia symptoms among low users. Improved understanding of the specific barrier and facilitators of UAS adherence may drive better long-term use and more personalized management strategies, including concomitant insomnia treatment.Clinical trials registrationRegistry: ClinicalTrials.gov; Name: Stimulation Therapy for Apnea: Reporting Thoughts (START); URL: https://clinicaltrials.gov/ct2/show/NCT04768543; Identifier: NCT04768543.CitationLuyster FS, Ni Q, Lee K, et al. Factors affecting obstructive sleep apnea patients' use of upper airway stimulation treatment. J Clin Sleep Med. 2022;18(9):2207-2215.

Project description:Study objectivesEvaluate the long-term durability of treatment response and safety of a nasal expiratory positive airway pressure (EPAP) device used to treat obstructive sleep apnea (OSA).DesignA prospective, multicenter, single-arm, open-label extension to a 3-month EPAP vs sham randomized clinical trialSetting13 sites including both academic and private sleep disorder centersPatientsOSA patients in the EPAP arm of the EPAP vs sham randomized study who used the EPAP device ≥ 4 h per night, ≥ 5 nights per week on average during months 1 and 2 of the 3-month trial and had ≥ 50% reduction in AHI or AHI reduction to < 10 documented by polysomnography, comparing the 3-month device-on PSG to the week-one device-off PSG.InterventionsTreatment with a nasal EPAP device (N = 41) for 12 months. Polysomnography (PSG) on the patients wearing the device was performed after 12 months of treatment. The month 12 device-on PSG data from the analyzable subject cohort (N = 34) was compared to the week 1 device-off PSG from the EPAP vs sham trial.Measurements and resultsOf the 51 patients eligible, 34 were still using the EPAP device at the end of 12 months. Median AHI was reduced from 15.7 to 4.7 events/h (week 1 device-off versus month 12 device-on). The decrease in the AHI (median) was 71.3% (p < 0.001). The median proportion of sleep time with snoring was reduced by 74.4% (p < 0.001). Over 12 months of EPAP treatment, the Epworth Sleepiness Scale decreased (11.1 ± 4.2 to 6.0 ± 3.2, p < 0.001), and the median percentage of reported nights used (entire night) was 89.3%.ConclusionsNasal EPAP significantly reduced the AHI, improved subjective daytime sleepiness and reduced snoring after 12 months of treatment. Long-term adherence to EPAP was excellent in those who had a positive clinical response at month 3 of the EPAP vs sham study.Clinical trial registrationClinicalTrials.gov TRIAL NAME: Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea (AERO C009E). URL: http://clinicaltrials.gov/ct2/show/NCT00849043?term=Ventus+Medical&rank=2.Registration numberNCT00849043.

Dataset Information

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

Publications

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

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