Clinical Studies

NightBalance SPT was trialed in 36 patients, over one month with 31 patients completing the protocol. Each night, 92.7% of the patients used the SPT for at least 4 hours. Median time spent sleeping in the supine position significantly decreased from 49.9% to 0.0% (p<0.001) and median AHI decreased from 16.4 to 5.2 (p<0.001). There was no change in sleep efficiency, but sleepiness decreased significantly and quality of life (QOL) improved.

Conclusion: The sleep position trainer provided successful treatment for POSA and was well tolerated by patients.

van Maanen, J. et al, The sleep position trainer: a new treatment for positional obstructive sleep apnea, Sleep and Breathing 2013; 17:771-779

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Over a 3-month period, the effectiveness of the SPT was compared to oral appliance therapy (OAT) in patients with mild to moderate POSA. Ninety-nine patients were randomized to either SPT or OAT with 81 patients completing the study. Median AHI was significantly reduced in both the SPT group (13.0 to 7.0, p<0.001) and the OAT group (11.7 to 9.1, p<0.001). Similar results were also seen in the percentage of patients using the therapy for at least 4 hours, 5 nights per week.

Conclusion: After 3-months, SPT and OAT were equally effective in reducing the AHI with high adherence.

Benoist, L. et al, A randomized, controlled trial of positional therapy versus oral appliance therapy for position-dependent sleep apnea, Sleep Medicine 2017;34:109-117

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Fifty-eight patients with mild to moderate sleep apnea from the previous study comparing SPT to OAT completed an extension to a 12-month follow-up. There were 29 patients in each group. AHI remained significantly reduced in both the SPT group (13.2 to 7.1, pp<0.001) and the OAT group (13.4 to 5.0, p<0.001) as well as the adherence.

Conclusion: the efficacy of SPT remained over the 12-month period in patients with mild to moderate POSA and was comparable to OAT. Adherence to the treatment remained high in both groups.

de Ruiter, M. et al, Durability of treatment effects of the sleep position trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial, Sleep and Breathing 2018; 22: 441-450

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Treating exclusive POSA (ePOSA) with NightBalance SPT was compared to auto-adjusting positive airway pressure (APAP) therapy in 110 patients in a 6-week randomized, crossover trial. The treatment AHI on SPT was 7.29 and 3.71/hour on APAP, which was within the primary endpoint’s delta of 5/hour. Nightly adherence of SPT was significantly greater on SPT (345.3 vs 286.98 minutes).

Conclusion: The AHI during PSG on the NightBalance was not importantly different from a clinical perspective to that on APAP.

Berry, Richard B. et al, NightBalance Sleep Position Treatment Device versus Auto-adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea, Journal of Clinical Sleep Medicine, 2019, Vol. 5, No.7, 947-956

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Standard positional therapy with the tennis ball technique had been an effective technique with very low compliance. New easier to wear in a supine sleep position trainer were compared to tennis balls to see a one-month adherence rate.

Conclusion: in mild POSA the SPT are equally effective in reducing AHI, but the SPT had a significantly improved sleep quality, quality of life and compliance.

Eijvogel, M. et al, Sleep position trainer versus tennis ball technique in positional obstructive sleep apnea syndrome, J Clin Sleep Med 2015; 11(2):139 – 147

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The sleep position trainer was compared to a mandibular advancement device (MAD) alone as well as a combined together in 20 patients with supine-dependent obstructive sleep apnea, with each treatment method undergoing a polysomnography test.

Conclusion: Combined therapy of SPT plus MAD led to a higher therapeutic efficacy when compared to the treatment modalities alone.

Dieltjens, M. et al, A promising concept of combinations therapy for positional obstructive sleep apnea, Sleep Breath (2015) 19:637-644

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In 101 patients, the SPT (52) was compared to non-treatment (49) for POSA with a PSG at entry, 2 months and 6 months. Compared to the control group, the SPT group had a reduction in total AHI and reduction of supine sleep.

Conclusion: After 6 months the 2-month effect of the SPT was maintained and an improvement in daytime sleepiness was noted. Overall, the SPT seems to be a successful therapy in well-selected patients with POSA.

Laub, R. et al, A Sleep Position Trainer of positional sleep apnea: a randomized, controlled trial, J Sleep Res (2017)

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A multicenter cohort study of mile and moderate POSA, with patients using the SPT for 6 months. Questionnaires were completed to assess sleepiness and quality of life were competed at baseline, 1, 3, and 6 months.

Conclusion: the SPT diminished the % of supine sleep and subjective sleepiness and improved sleep related quality of life in patient with mild to moderate POSA. Effects appeared to be sustained over the 6 months.

Van Maanen, J. et al, Long-term effectiveness and compliance of positional therapy with the sleep position trainer in the treatment of positional obstructive sleep apnea syndrome, Sleep, Vol 37, No. 7, 2014

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After upper airway surgery, many patients still have residual positional obstructive sleep apnea. Before and after a 3-month treatment with positional therapy, a PSG was used to determine changes in AHI and sleep position parameters. AHI to 12.5/hr. from 18.3/hr. along with a compliance rate of 89%.

Conclusion: overall therapeutic effectiveness is increased with SPT in a complex OSA population that has residual POA after surgical intervention.

Benoist, Positional therapy in patients with residual positional obstructive sleep apnea after upper airway surgery

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