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

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ClinicalTrials.gov Identifier: NCT02114424
Recruitment Status : Unknown
Verified April 2014 by Philip Tønnesen, M.D., Glostrup University Hospital, Copenhagen.
Recruitment status was:  Not yet recruiting
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Philip Tønnesen, M.D., 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea (OSAS) Device: Positional vibrator belt Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Night Balance for Positional Obstructive Sleep Apnea Syndrome (POSAS) A Prospective, Randomized, Controlled Open Trial in Daily Clinical Practice
Study Start Date : May 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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

No Intervention: No Night balance
the first 2 months without Night Balance



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


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114424


Contacts
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Contact: Philip Toennesen, M.D., Ph.D. (45)51264850 philip.toennesen.01@regionh.dk

Locations
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Denmark
Glostrup University Hospital Not yet recruiting
Glostrup, Denmark, 2600
Principal Investigator: Philip Toennesen, M.D., Ph.D.         
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
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Principal Investigator: Philip Toennesen, M.D., Ph.D. GlsotrupUH

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.

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Responsible Party: Philip Tønnesen, M.D., Senior consultant, Dept. of Sleep, Dept. of Clin. neurophysiology, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT02114424     History of Changes
Other Study ID Numbers: H-3-2014-039
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014
Keywords provided by Philip Tønnesen, M.D., Glostrup University Hospital, Copenhagen:
Positional Obstructive sleep apnea syndrome (POSAS)
Obstructive sleep apnea syndrome (OSAS)
Apnea-Hypnea Index (AHI)
Sleep questionnaire
Positional sleep apnea belt
Adverse events
Compliance
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases