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Physiological Study of the Critical Closing Airway Pressure in a Population of Didgeridoo Players (SASDICrit)

Primary Purpose

Sleep Apnea Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measurement of critical airway closing pressure
Respiratory function tests
pharyngometry
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep Apnea Syndromes focused on measuring sleep apnea syndrome, didgeridoo, uper airway

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion criteria : 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. Exclusion criteria : Participation in a research protocol involving the human person in the previous months if an exclusion instruction is given in this protocol 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"

Sites / Locations

  • Justine FrijaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

didgeridoo players

oboe players

control

Arm Description

subjects having a regular practice of didgeridoo

subjects having a regular practice of the oboe

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Value of the slope of response to CO2 in each of the three groups
pharyngeal volume

Full Information

First Posted
October 31, 2022
Last Updated
October 31, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05606653
Brief Title
Physiological Study of the Critical Closing Airway Pressure in a Population of Didgeridoo Players
Acronym
SASDICrit
Official Title
Physiological Study of the Critical Closing Airway Pressure in a Population of Didgeridoo Players
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Some studies have shown the benefit of playing the didgeridoo, a wind musical instrument of Aboriginal origin, on the risk of obstructive sleep apnea hypopnea syndrome (OSAHS) and on OSAHS itself. Thus, didgeridoo players are less at risk of OSAHS and the practice of this instrument reduces the severity of this syndrome. To date, there are very few studies on the physiological mechanisms involved in the practice of the didgeridoo to explain this reduction in risk and impact on OSAHS. The rare studies carried out show a great participation of the dilator muscles of the pharynx. We can also note that the didgeridoo is practiced with a particular breathing technique allowing air to be expelled while inhaling. This technique is called circular breathing. This breathing is acquired by working on the control of these dilator muscles of the pharynx but also by becoming aware of its ventilatory needs. Thus it is for the players to learn to breathe according to the needs without disturbing the piece. This respiratory learning, ventilation modulation, not explored until now, could influence the sensitivity of the central and peripheral chemoreceptors of the player with respect to his pCO2 and his pO2. We know the role of this sensitivity in the pathophysiology of SAS. In this work we therefore seek to highlight a benefit to the practice of the didgeridoo on the critical pressure of pharyngeal closure involving the dilator muscles of the pharynx but also a benefit in terms of gas exchange by analyzing the slope of response to CO2 . We will compare the effect of using the didgeridoo with that of another wind instrument, the oboe, on these respiratory parameters. We chose this instrument because a study showed a lower risk of SAS in a population of oboe players. However, in the practice of this instrument, circular breathing is not used. It would therefore be a comparative observational study with the recruitment of three groups of subjects in order to: Compare didgeridoo players with subjects not playing a wind instrument; Compare didgeridoo players with players of another wind instrument. There is no fixed reference value for Pcrit in healthy subjects, partly due to the heterogeneity of VAS collapsibility in healthy subjects (Pcrit is between -5 and -25 cm d water according to the studies), and on the other hand the wide variety of measurement methods. It is therefore necessary to have control groups. Given the epidemiology of obstructive SAS and the exploratory nature of this study, we decided to include only male subjects, which will also make it possible to eliminate the effects of sex on respiratory chemosensitivity. Similarly, given the epidemiology of SAS, an age limit of 85 years was introduced in order not to overlook the effects of aging on the collapsibility of the VAS and chemosensitivity. Finally, subjects will be matched on age (+/- 5 years) and body mass index (BMI, +/- 2.5 kg/m2) as there is a relationship between age/BMI and the collapsibility of the VAS on the one hand, and between age/BMI and the occurrence of SAS on the other hand. "

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
sleep apnea syndrome, didgeridoo, uper airway

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
didgeridoo players
Arm Type
Other
Arm Description
subjects having a regular practice of didgeridoo
Arm Title
oboe players
Arm Type
Other
Arm Description
subjects having a regular practice of the oboe
Arm Title
control
Arm Type
Other
Arm Description
control subjects without diagnosed SAS, at low risk of SAS on the Berlin questionnaire and the STOP BANG questionnaire
Intervention Type
Other
Intervention Name(s)
Measurement of critical airway closing pressure
Intervention Description
Measurement of critical airway closing pressure
Intervention Type
Other
Intervention Name(s)
Respiratory function tests
Intervention Description
CO2 response test
Intervention Type
Other
Intervention Name(s)
pharyngometry
Intervention Description
measure of the pharyngometry
Primary Outcome Measure Information:
Title
values of the critical closing pressure of the VAS (Pcrit) in patients of the "Didgeridoo players" group and the "control" group
Time Frame
one day
Secondary Outcome Measure Information:
Title
Value of the slope of response to CO2 in each of the three groups
Time Frame
one day
Title
pharyngeal volume
Time Frame
one day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria : 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. Exclusion criteria : Participation in a research protocol involving the human person in the previous months if an exclusion instruction is given in this protocol 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"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frija-Masson Justine, MD
Phone
01 40 25 84 01
Ext
33
Email
justine.frija@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gaudier Simon, MD
Phone
03 20 44 59 62
Ext
33
Email
simon.GAUDIER@CHRU-LILLE.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frija-Masson Justine, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Justine Frija
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine Frija
Phone
01 40 25 84 01
Ext
33
Email
justine.frija@aphp.fr
First Name & Middle Initial & Last Name & Degree
Gaudier Simon
Phone
03 20 44 59 62
Ext
33
Email
simon.GAUDIER@CHRU-LILLE.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Physiological Study of the Critical Closing Airway Pressure in a Population of Didgeridoo Players

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