Influence of Didgeridoo Practice on UA Obstruction Levels... | NCT02159664

Studies
Influence of Didgeridoo Practice on UA Obstruction Levels in Moderate OSA

NCT02159664

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Status

Terminated

Last Update Posted

Sep 11, 2017Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Sleep Apnea

Interventions

didgeridoo practice

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

difficulty to recrut patients

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Jun 6, 2014

First Submission Date that Met QC Criteria

Jun 6, 2014

First Posted Date

Jun 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2017

Last Update Posted Date

Sep 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marie Bruyneel, Influence of didgeridoo pratice on upper airways obstruction levels in moderate obstructive sleep apnea patients, Centre Hospitalier Universitaire Saint PierrePrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire Saint PierreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
didgeridoo practice	Experimental		Other: didgeridoo practice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
didgeridoo practice	Other	instrument lessons, 1X/w and daily practice, 20 min /d	didgeridoo practice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
upper airways obstruction levels	assessed by drug-induced sleep endoscopy	3 months

Secondary Outcomes

Measure	Description	Time Frame
apnea-hypopnea index	assessed by polysomnography	3 months

Other Outcomes

Measure	Description	Time Frame
subjective sleep quality and sleepiness	assessed by questionnaires	3 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie Bruyneel, MD	CHU St Pierre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU St Pierre		Brussels		1000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided