Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS)

NCT ID: NCT02114424

Last Updated: 2014-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-02-29

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.

Conditions

Obstructive Sleep Apnea (OSAS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Positional vibrator belt

Positional belt to avoid supine sleep.

Group Type: ACTIVE_COMPARATOR

Positional vibrator belt

Intervention Type: DEVICE

Belt with vibarator to avoid sleep supine

No Night balance

the first 2 months without Night Balance

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Positional vibrator belt

Belt with vibarator to avoid sleep supine

Intervention Type: DEVICE

Other Intervention Names

Night Balance, B.V,, 2629 JD Delft, The Netherlands

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Philip Tønnesen, M.D.

Senior consultant, Dept. of Sleep, Dept. of Clin. neurophysiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Toennesen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

GlsotrupUH

Locations

Glostrup University Hospital

Glostrup Municipality, , Denmark

Countries

Denmark

Central Contacts

Philip Toennesen, M.D., Ph.D.

Role: CONTACT

philip.toennesen.01@regionh.dk

(45)51264850

References

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.

Reference Type: BACKGROUND

Other Identifiers

H-3-2014-039

Identifier Type: -

Identifier Source: org_study_id