Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obstructive Sleep Apnea (OSAS)

Intervention / Treatment
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* Device: Positional vibrator belt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Positional vibrator belt<br>Positional belt to avoid supine sleep. | Device: Positional vibrator belt<br>* Belt with vibarator to avoid sleep supine<br>* Other names: Night Balance, B.V,, 2629 JD Delft, The Netherlands;|
| No Intervention: No Night balance<br>the first 2 months without Night Balance | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adverse events, Compliance, Positional Obstructive sleep apnea syndrome (POSAS), Obstructive sleep apnea syndrome (OSAS), Apnea-Hypnea Index (AHI), Sleep questionnaire, Positional sleep apnea belt