NCT02159664

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

June 6, 2014

Last Update Submit

September 8, 2017

Conditions

Sleep Apnea

Keywords

didgeridoosleep apneadrug induced sleep endoscopy

Outcome Measures

Primary Outcomes (1)

  • upper airways obstruction levels

    assessed by drug-induced sleep endoscopy

    3 months

Secondary Outcomes (1)

  • apnea-hypopnea index

    3 months

Other Outcomes (1)

  • subjective sleep quality and sleepiness

    3 months

Study Arms (1)

didgeridoo practice

EXPERIMENTAL
Other: didgeridoo practice

Interventions

didgeridoo practiceOTHER

instrument lessons, 1X/w and daily practice, 20 min /d

didgeridoo practice

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • moderate OSA, non obese

You may not qualify if:

  • not willing play didgeridoo age\<18 significant lung, cardiac disease neuromuscular disease psychiatric disorders drugs with influence on respiratory drive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU St Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Marie Bruyneel, MD

    CHU St Pierre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Influence of didgeridoo pratice on upper airways obstruction levels in moderate obstructive sleep apnea patients

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 10, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

BE(1)