Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS)

Phase 2

• Conditions: Obstructive Sleep Apnea (OSAS)
• Interventions: Device: Positional vibrator belt

• Registration Number: NCT02114424
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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 Timeline

• Status Verified: 2014-04
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-13
• Last Update Submitted: 2014-04-13
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15
• Study Start: 2014-05
• Primary Completion: 2015-06
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positional vibrator belt	Positional vibrator belt	Positional belt to avoid supine sleep.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Glostrup University Hospital; 🇩🇰 Glostrup, Denmark