Obstructive Sleep Apnea (OSAS) Clinical Trial
— POSASOfficial title:
Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS) A Prospective, Randomized, Controlled Open Trial in Daily Clinical Practice
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.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | February 2016 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - AHI supine = AHI non-supine x 2, - AHI supine = 10 - AHI non-supine <10 - 10 -90 % sleep time in supine position - Daytime tiredness and/or disturbed sleep and/or snoring Exclusion Criteria: - Not able or willing to cooperate - Age <18 years - Central Sleep Apnea - Night or shifting work - Severe chronic heart failure or severe COPD - A medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy) - Seizure disorder - A known medical history of mental retardation, memory disorders or psychiatric disorders - The inability to provide informed consent - Pacemaker - Pain in joints or shoulder - Other reasons unable to sleep in lateral positions. - Pregnant females or females that plan pregnancy in study period (problems sleeping supine) - Breastfeeding females in study period (other reasons for disturbed sleep) - Plan weight reduction in study period - Plan to quit smoking in study period |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Glostrup University Hospital | Glostrup |
| Lead Sponsor | Collaborator |
|---|---|
| Glostrup University Hospital, Copenhagen |
Denmark,
23. van der Star A, Mekking S, van Riet M. The technical validation of the Sleep Position Trainer. Nightbalance Research and Development [Internet]. 2012 Oct [cited 2013 Dec 6]:1-12. Available from http://www.nightbalance.com/research.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine and AHI). | AFter 2 months assessment will be done by sleep questionnaires and CRM | After 2 months | No |
| Secondary | Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine). | ALl wil ahve a new CRM after 6 months with Night Balance and sleep questionnaires | 6 months after entry | Yes |