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. 2019 May 1;2019(5):CD010990. doi: 10.1002/14651858.CD010990.pub2

ISRCTN16170657.

Trial name or title Comparison of the NightBalance Lunoa to positive airway pressure (PAP) for the treatment of positional obstructive sleep apneas (POSA)
Methods Randomised cross‐over trial
Participants 150 (95 treatment‐naive and 55 PAP non‐adherent patients)
All adults with diagnosis of POSA (AHI > 15 with sleepiness or co‐morbidities like atrial fibrillation, hypertension; supine AHI at least twice lateral AHI; Lateral AHI < 10; supine time > 30% and < 70%) who are either treatment‐naive or PAP non‐adherent (defined as current positive airway pressure user with < 3 h/night in the last 3 months per adherence download), and willing to use the positive airway pressure device per protocol
Interventions Lunoa sleep position therapy vs APAP
Outcomes Primary objective: AHI, adherence
Secondary objective: ESS, SF‐36, Euroquol 5D (EQ5D), Pichot fatigue scale, patient comfort and satisfaction on Likert scale, adverse events, health economics and resource utilisation
Starting date 1 August 2018
Contact information K. van der Geest
research@nightbalance.com;
Benoordenhoutseweg 46‐13
Den Haag
2596BC
Netherlands
Notes