NCT05606653

Brief Summary

Obstructive sleep apnea is characterised by an abnormal upper airway collapsibility. Upper airway collapsibility can be evaluated through critical closure airway pressure (Pcrit). Didgeridoo is a traditional australian musical instrument involving circular respiration, a breathing technique involving mouth muscles. We hypothesize that didgeridoo players have a lower risk of airway collapsibility due to circular breathing technique

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

October 31, 2022

Last Update Submit

March 19, 2024

Conditions

Sleep Apnea Syndromes

Keywords

sleep apnea syndromedidgeridoouper airway

Outcome Measures

Primary Outcomes (1)

  • values of the critical closing pressure of the VAS (Pcrit) in patients of the "Didgeridoo players" group and the "control" group

    one day

Secondary Outcomes (2)

  • Value of the slope of response to CO2 in each of the three groups

    one day

  • pharyngeal volume

    one day

Study Arms (3)

didgeridoo players

OTHER

subjects having a regular practice of didgeridoo

Other: Measurement of critical airway closing pressureOther: Respiratory function testsOther: pharyngometry

oboe players

OTHER

subjects having a regular practice of the oboe

Other: Measurement of critical airway closing pressureOther: Respiratory function testsOther: pharyngometry

control

OTHER

control subjects without diagnosed SAS, at low risk of SAS on the Berlin questionnaire and the STOP BANG questionnaire

Other: Measurement of critical airway closing pressureOther: Respiratory function testsOther: pharyngometry

Interventions

Measurement of critical airway closing pressureOTHER

Measurement of critical airway closing pressure

controldidgeridoo playersoboe players
Respiratory function testsOTHER

CO2 response test

controldidgeridoo playersoboe players
pharyngometryOTHER

measure of the pharyngometry

controldidgeridoo playersoboe players

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patient
  • Age ≥18 and ≤85 years old
  • Free, informed and written consent
  • Affiliation to a social security scheme
  • For "Didgeridoo players" group:
  • \- Regular practice of the didgeridoo defined by a practice of more than 3 times a week, for more than 1 year and having acquired the circular breathing technique.
  • For "Oboe players" group:
  • \- Regular practice of the oboe defined by a practice of more than 3 sessions per week for more than 1 year.
  • For "Control cases" group:
  • \- Patient free from SAS and at low risk of SAS on the Berlin questionnaire and the STOP BANG questionnaire.

You may not qualify if:

  • Use of respiratory depressants or sedatives, systemic corticosteroid therapy
  • Unstable cardiovascular disease (cardiovascular event less than a month old)
  • Recent ENT surgery (less than 6 months)
  • Known central neurological pathology
  • Psychiatric pathology according to DSM-V criteria, unbalanced
  • Pulsed oxyhemoglobin saturation \< 88% at rest, while awake
  • Patient under guardianship or curators
  • Patient under AME
  • Absence of prior medical examination"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Justine Frija

Paris, 75018, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

  • Frija-Masson Justine, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 7, 2022

Study Start

September 16, 2021

Primary Completion

July 7, 2023

Study Completion

January 16, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations

FR(1)