Obstructive Sleep Apnea (OSAS)
Conditions
Keywords
Positional Obstructive sleep apnea syndrome (POSAS), Obstructive sleep apnea syndrome (OSAS), Apnea-Hypnea Index (AHI), Sleep questionnaire, Positional sleep apnea belt, Adverse events, Compliance
Brief 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.
Interventions
DEVICEPositional vibrator belt
Belt with vibarator to avoid sleep supine
Sponsors
Glostrup University Hospital, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine and AHI). | After 2 months | AFter 2 months assessment will be done by sleep questionnaires and CRM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine). | 6 months after entry | ALl wil ahve a new CRM after 6 months with Night Balance and sleep questionnaires |
Countries
Denmark
Contacts
Primary ContactPhilip Toennesen, M.D., Ph.D.
Outcome results
None listed