Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS) A Prospective, Randomized, Controlled Open Trial in Daily Clinical Practice
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine and AHI).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine).(6 months after entry)
Investigators
Philip Tønnesen, M.D.
Senior consultant, Dept. of Sleep, Dept. of Clin. neurophysiology
Glostrup University Hospital, Copenhagen