NCT04036864

Brief Summary

Singers are over-represented in phoniatric consultation; they present increased risk of developing voice disorders. They represent a specific population among phoniatric patients (specific singing-voice complaints, increased sensitivity to voice). Singing-voice disorder is called dysodia in the same way as dysphonia, which refers to speaking-voice disorders. The diagnosis of dysodia is made after a laryngeal examination and a voice assessment to identify patient's speech and singing difficulties. Most studies on prevalence of voice disorders in singers come from the American continent. Very few descriptions of this population have been made in France. Voice assessment of dysodic singers includes aerodynamic voice measurements. The use of aerodynamic measurements for the diagnosis of voice pathologies is now widely demonstrated. These parameters include measurements of estimated subglottal pressure (ESGP), phonation threshold pressure (PTP) (minimum pressure to initiate a sound) and oral airflow (OAF). They depend on the level of training of singers and the type of vocal dysfunction. Aerodynamic behaviours of dysodic singers have not yet been described, although they can help to better identify the singer's vocal difficulties and could be essential parameters for targeting more precisely rehabilitation exercises proposed in voice therapy. This study aims to describe the characteristics of a French population of singers consulting in phoniatrics and their aerodynamic behaviours. Do the singers' aerodynamic parameters (pressure, flow) reflect the dysfunctions in singing voice? Based on results of the literature on speaking and singing non-pathological voice, the investigators hypothesize that during voice assessment, ESGP values will be increased and OAF ones will be decreased over the entire vocal range of the singer in case of voice pathology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

July 22, 2019

Last Update Submit

December 28, 2020

Conditions

Keywords

Singers

Outcome Measures

Primary Outcomes (3)

  • Aerodynamic data : estimated subglottal pressure

    estimated subglottal pressure (values in hPa)

    1 day

  • Aerodynamic data : phonation pressure threshold

    phonation pressure threshold (values in hPa)

    1 day

  • Aerodynamic data : oral airflow rate

    oral airflow rate (values in l/s).

    1 day

Secondary Outcomes (9)

  • social and medical data : age

    1 day

  • social and medical data : sex

    1 day

  • social and medical data : occupation

    1 day

  • social and medical data : singing style

    1 day

  • social and medical data : level of training

    1 day

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have consulted the phoniatrician (Dr Amy de la Bretèque) of the ENT department of the Gui de Chauliac hospital between January 2015 and June 2018.

You may qualify if:

  • have consulted Dr Amy de la Bretèque, phoniatrist, between January 2015 and June 2018
  • be a singer (professional or amateur)
  • be over 18 years old

You may not qualify if:

  • under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Study Officials

  • Marion BEAUD

    UH MONTPELLIER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 30, 2019

Study Start

March 1, 2019

Primary Completion

November 1, 2020

Study Completion

June 1, 2021

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations