NCT02114424

Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS)

Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS) A Prospective, Randomized, Controlled Open Trial in Daily Clinical Practice

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Glostrup University Hospital, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

POSAS can be treated with CPAP however there is now evidence from a few studies that Night Balance is effective in POSAS. Night Balance seems to be better accepted than CPAP so we would like to examine if we could find similar results in routine clinical work and especially we would like to confirm the subjective effects with objective measures i.e. a reduction in AHI in the supine position during sleep.

Detailed description

Primary aim: Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine). Secondary aim: Efficacy and adherence of Night Balance in POSAS after a 6 months period (Sleep supine and compliance and AHI). Nigh Balance is a vibrator and a belt that vibrate when laying supine so that after a few days you will not sleep supine.

Conditions

• Obstructive Sleep Apnea (OSAS)

Interventions

Type	Name	Description
DEVICE	Positional vibrator belt	Belt with vibarator to avoid sleep supine

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-06-01
• Completion: 2016-02-01
• First posted: 2014-04-15
• Last updated: 2014-04-15

Locations

1 site across 1 country: Denmark