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

Primary Purpose

Obstructive Sleep Apnea (OSAS)

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Positional vibrator belt
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea (OSAS) focused on measuring Positional Obstructive sleep apnea syndrome (POSAS), Obstructive sleep apnea syndrome (OSAS), Apnea-Hypnea Index (AHI), Sleep questionnaire, Positional sleep apnea belt, Adverse events, Compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Glostrup University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Positional vibrator belt

No Night balance

Arm Description

Positional belt to avoid supine sleep.

the first 2 months without Night Balance

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2014
Last Updated
April 13, 2014
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02114424
Brief Title
Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS)
Acronym
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Positional vibrator belt
Arm Type
Active Comparator
Arm Description
Positional belt to avoid supine sleep.
Arm Title
No Night balance
Arm Type
No Intervention
Arm Description
the first 2 months without Night Balance
Intervention Type
Device
Intervention Name(s)
Positional vibrator belt
Other Intervention Name(s)
Night Balance, B.V,, 2629 JD Delft, The Netherlands
Intervention Description
Belt with vibarator to avoid sleep supine
Primary Outcome Measure Information:
Title
Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine and AHI).
Description
AFter 2 months assessment will be done by sleep questionnaires and CRM
Time Frame
After 2 months
Secondary Outcome Measure Information:
Title
Efficacy and adherence of Night Balance in POSAS versus no therapy after 2 months (Sleep supine).
Description
ALl wil ahve a new CRM after 6 months with Night Balance and sleep questionnaires
Time Frame
6 months after entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Toennesen, M.D., Ph.D.
Phone
(45)51264850
Email
philip.toennesen.01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Toennesen, M.D., Ph.D.
Organizational Affiliation
GlsotrupUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glostrup University Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Toennesen, M.D., Ph.D.

12. IPD Sharing Statement

Citations:
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.
Results Reference
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Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS)

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