Back to resultsInfluence of Didgeridoo Practice on UA Obstruction Levels in Moderate OSA
Primary Purpose
Sleep Apnea
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
didgeridoo practice
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring didgeridoo, sleep apnea, drug induced sleep endoscopy
Eligibility Criteria
Inclusion Criteria:
- moderate OSA, non obese
Exclusion Criteria:
- not willing play didgeridoo age<18 significant lung, cardiac disease neuromuscular disease psychiatric disorders drugs with influence on respiratory drive
Sites / Locations
- CHU St Pierre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
didgeridoo practice
Arm Description
Outcomes
Primary Outcome Measures
upper airways obstruction levels
assessed by drug-induced sleep endoscopy
Secondary Outcome Measures
apnea-hypopnea index
assessed by polysomnography
Full Information
NCT ID
NCT02159664
First Posted
June 6, 2014
Last Updated
September 8, 2017
Sponsor
Centre Hospitalier Universitaire Saint Pierre
1. Study Identification
Unique Protocol Identification Number
NCT02159664
Brief Title
Influence of Didgeridoo Practice on UA Obstruction Levels in Moderate OSA
Official Title
Influence of Didgeridoo Practice on Upper Airways Obstruction Levels in Moderate Obstructive Sleep Apnea Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
difficulty to recrut patients
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Didgeridoo practice has been shown to improve OSA severity. The aim of our study is to assess the changes in upper airways obstruction levels before and after Didgeridoo practice in moderate OSA patients.
Detailed Description
Didgeridoo practice has been shown to improve Obstructive Sleep Apnea (OSA) severity. The aim of our study is to assess the changes in upper airways obstruction levels, evaluated by sleep endoscopy, before and after 3 months of Didgeridoo practice in moderate non obese OSA patients. Severity of OSA will also be documented by polysomnography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
didgeridoo, sleep apnea, drug induced sleep endoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
didgeridoo practice
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
didgeridoo practice
Intervention Description
instrument lessons, 1X/w and daily practice, 20 min /d
Primary Outcome Measure Information:
Title
upper airways obstruction levels
Description
assessed by drug-induced sleep endoscopy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
apnea-hypopnea index
Description
assessed by polysomnography
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
subjective sleep quality and sleepiness
Description
assessed by questionnaires
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
moderate OSA, non obese
Exclusion Criteria:
not willing play didgeridoo age<18 significant lung, cardiac disease neuromuscular disease psychiatric disorders drugs with influence on respiratory drive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Bruyneel, MD
Organizational Affiliation
CHU St Pierre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU St Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
12. IPD Sharing Statement
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Influence of Didgeridoo Practice on UA Obstruction Levels in Moderate OSA
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