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DysodiaAeroDysodiaProNCT04036864

Singing-voice Disorders and Aerodynamic Profiles in Dysodic Singers

An observational study of Dysodia, run by University Hospital, Montpellier at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dysodia
How many people
100 participants
Where
1 siteFrance
Study dates
1 Mar 2019to 1 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • under 18 years old

Trial locations and contacts

1 site in 1 country.

France1 site
  • Uh Montpellier

    Montpellier, 34295

Other trials in France

About this study

Official title: Retrospective Study of Singing-voice Disorders and Aerodynamic Profiles in Dysodic Singers

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.

Read the detailed description

Singers are over-represented in phoniatric consultation; they present increased risk of developing voice disorders whether they are amateurs or professionals. They represent a specific population among phoniatric patients because of their increased sensitivity to the slightest voice change that makes them consult earlier than non-. In addition, their complaints are specific to singing voice. The most common lesion found in singers is vocal-fold nodule. It comes from a vocal straining characterized by the use of a pressed phonation mode, resulting in an increased subglottal pressure and a decreased flow rate.

Singing-voice disorder is called dysodia in the same way as dysphonia, which refers to speaking-voice disorders. Dysodia results in a variety of symptoms. Acoustic signs are the most numerous: tonal anomalies (lack of accuracy, reduction of vocal range); dynamic anomalies (problem to sing softly or loudly); timbre abnormalities (vibrato problems, strained voice, roughness, difficulties on attacks). Dysodia also results in respiratory disorders, physical signs, psychological consequences and damage to hedonistic properties (loss of comfort, vocal endurance, musicality). It can reach amateur or professional singers. For professional singers, voice is the main working tool. When they have dysodia, professional difficulties can be temporary or even lead to the loss of work. In addition, dysodia can lead to financial loss and well-documented anxiety. For amateur singers, dysodia hinders their musical practice, thus limiting the recognized benefits of choral singing on cohesion, social integration and personal development. The diagnosis of dysodia is made after a laryngeal examination and a vocal assessment to identify patient's speech difficulties.

Voice assessment includes subjective voice analyses but also instrumental analyses that include acoustic, electrophysiological and aerodynamic voice measurements. The interest of aerodynamic parameters for the diagnosis of vocal 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 air flow (OAF). They depend on the level of training of singers and the type of vocal dysfunction. These aerodynamic data are collected with devices such as the Assisted Voice Evaluation Device (EVA2©) used in the laryngeal department of the Gui de Chauliac University Hospital. These pressure and flow parameters are higher in opera singers than in non-singers. In clinical practice, the ESGP and PTP are higher during vocal straining in dysphonic patients. Concerning OAF, results remain controversial: increase with vocal effort in euphonics non-singers; decrease with intensity increase in euphonic non-singers. 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.

In addition, most studies on prevalence of vocal disorders in singers come from the American continent. Very few descriptions of this population have been made in France. The few that exist are quite old or involve limited samples. Moreover, to date, no study has explored the aerodynamic profiles (flow and pressure) of singers, although these profiles are considered to be relevant clinical indicators to describe the singer's vocal difficulties and thus precise more specific therapeutic objectives.

In this context, our project aims to fill these gaps by describing a French population of singers consulting in phoniatrics and describing 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, the values of ESGP and PTP will be increased and that those of OAF will be decreased over the entire range of the singer in case of vocal pathology

Conditions
Dysodia
Keywords
Singers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aerodynamic data : estimated subglottal pressure

    estimated subglottal pressure (values in hPa)

    Measured: 1 day

  2. Aerodynamic data : phonation pressure threshold

    phonation pressure threshold (values in hPa)

    Measured: 1 day

  3. Aerodynamic data : oral airflow rate

    oral airflow rate (values in l/s).

    Measured: 1 day

Secondary outcomes (9)
  1. social and medical data : age

    age (yo)

    Measured: 1 day

  2. social and medical data : sex

    sex (male or female)

    Measured: 1 day

  3. social and medical data : occupation

    occupation : profession noted in the file by the phoniatrician

    Measured: 1 day

  4. social and medical data : singing style

    singing style : opera, concert/oratorio/recital, recording artist, pop, rock, jazz, gospel and soul, country and western, world music, vocal groups, French commercial singing.

    Measured: 1 day

  5. social and medical data : level of training

    level of training : superstars, international singers, national/big city singers, regional/touring, local community (including semiprofessionals), full-time students of singing and amateur.

    Measured: 1 day

  6. social and medical data : voice complaint

    voice complaint : vocal difficulties reported by the patient to the phoniatrician and noted in the medical files

    Measured: 1 day

  7. social and medical data : phoniatric diagnosis

    phoniatric diagnosis : diagnosis by the phoniatrician specifying whether there are laryngeal lesions

    Measured: 1 day

  8. social and medical data : tobacco consumption

    tobacco consumption (yes or no, volume)

    Measured: 1 day

  9. social and medical data : voice treatment

    voice treatment : treatment proposed by the phoniatrician (no treatment, surgery, voice therapy)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2019
  2. Study start1 Mar 2019
  3. Primary completion1 Nov 2020
  4. Study completion1 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04036864
Sponsor's protocol ID
RECHMPL19_0339
Acronym
AeroDysodiaPro
Status last verified
Dec 2020
First submitted
22 Jul 2019
Last updated
29 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: NC

Questions about this trial

What is this clinical trial studying?

An observational study of Dysodia, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aerodynamic data : estimated subglottal pressure (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.

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