Clinical trial NCT02114424: Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS)
Official title: Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS) A Prospective, Randomized, Controlled Open Trial in Daily Clinical Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Obstructive Sleep Apnea (OSAS)
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
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine and AHI).
timeFrame: After 2 months
Secondary outcomes:
measure: Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine).
timeFrame: 6 months after entry
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup University Hospital
Study officials:
affiliation: GlsotrupUH
name: Philip Toennesen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.