Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS) (POSAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02114424|
Recruitment Status : Unknown
Verified April 2014 by Philip Tønnesen, M.D., Glostrup University Hospital, Copenhagen.
Recruitment status was: Not yet recruiting
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea (OSAS)||Device: Positional vibrator belt||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS) A Prospective, Randomized, Controlled Open Trial in Daily Clinical Practice|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||February 2016|
Active Comparator: Positional vibrator belt
Positional belt to avoid supine sleep.
Device: Positional vibrator belt
Belt with vibarator to avoid sleep supine
Other Name: Night Balance, B.V,, 2629 JD Delft, The Netherlands
No Intervention: No Night balance
the first 2 months without Night Balance
- Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine and AHI). [ Time Frame: After 2 months ]AFter 2 months assessment will be done by sleep questionnaires and CRM
- Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine). [ Time Frame: 6 months after entry ]ALl wil ahve a new CRM after 6 months with Night Balance and sleep questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114424
|Contact: Philip Toennesen, M.D., Ph.D.||(45)firstname.lastname@example.org|
|Glostrup University Hospital||Not yet recruiting|
|Glostrup, Denmark, 2600|
|Principal Investigator: Philip Toennesen, M.D., Ph.D.|
|Principal Investigator:||Philip Toennesen, M.D., Ph.D.||GlsotrupUH|