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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positional vibrator belt | Active Comparator | Positional belt to avoid supine sleep. |
|
| No Night balance | No Intervention | the first 2 months without Night Balance |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positional vibrator belt | Device | Belt with vibarator to avoid sleep supine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip Toennesen, M.D., Ph.D. | Contact | (45)51264850 | philip.toennesen.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Philip Toennesen, M.D., Ph.D. | GlsotrupUH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glostrup University Hospital | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |