Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS) (POSAS)

Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS) A Prospective, Randomized, Controlled Open Trial in Daily Clinical Practice

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea (OSAS)
• Intervention / Treatment: Device: Positional vibrator belt

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Philip Toennesen, M.D., Ph.D.; Phone Number: (45)51264850; Email: philip.toennesen.01@regionh.dk

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Glostrup University Hospital
    • Principal Investigator: Philip Toennesen, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Positional vibrator belt; Positional belt to avoid supine sleep.	Device: Positional vibrator belt; Belt with vibarator to avoid sleep supine; Other Names: Night Balance, B.V,, 2629 JD Delft, The Netherlands
No Intervention: No Night balance; the first 2 months without Night Balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine and AHI).	AFter 2 months assessment will be done by sleep questionnaires and CRM	After 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine).	ALl wil ahve a new CRM after 6 months with Night Balance and sleep questionnaires	6 months after entry

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Investigators: Principal Investigator: Philip Toennesen, M.D., Ph.D., GlsotrupUH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 13, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 13, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Compliance; Adverse events; Sleep questionnaire; Positional Obstructive sleep apnea syndrome (POSAS); Obstructive sleep apnea syndrome (OSAS); Apnea-Hypnea Index (AHI); Positional sleep apnea belt
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: H-3-2014-039