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 |