Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS)

Glostrup University Hospital, Copenhagen

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Obstructive Sleep Apnea (OSAS)

Treatments: Device: Positional vibrator belt

Study type: Interventional

Funder types: Other

Identifiers

NCT02114424

H-3-2014-039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Positional vibrator belt

Active Comparator group

Description:

Positional belt to avoid supine sleep.

Treatment:

Device: Positional vibrator belt

No Night balance

No Intervention group

Description:

the first 2 months without Night Balance