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.
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.
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.
Aerodynamic data : estimated subglottal pressure
estimated subglottal pressure (values in hPa)
Measured: 1 day
Aerodynamic data : phonation pressure threshold
phonation pressure threshold (values in hPa)
Measured: 1 day
Aerodynamic data : oral airflow rate
oral airflow rate (values in l/s).
Measured: 1 day
Secondary outcomes (9)
social and medical data : age
age (yo)
Measured: 1 day
social and medical data : sex
sex (male or female)
Measured: 1 day
social and medical data : occupation
occupation : profession noted in the file by the phoniatrician
Measured: 1 day
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
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
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
social and medical data : phoniatric diagnosis
phoniatric diagnosis : diagnosis by the phoniatrician specifying whether there are laryngeal lesions
Measured: 1 day
social and medical data : tobacco consumption
tobacco consumption (yes or no, volume)
Measured: 1 day
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.
- First posted30 Jul 2019
- Study start1 Mar 2019
- Primary completion1 Nov 2020
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysodiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- GIPSA-lab, Grenoble, France
- Responsible party
- Sponsor
- Investigators
- Marion BEAUD, Principal investigator, UH MONTPELLIER
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Singing-voice Disorders and Aerodynamic Profiles in Dysodic Singers
- ClinicalTrials.gov ID
- NCT04036864
- Acronym / sponsor ID
- AeroDysodiaPro / RECHMPL19_0339
- Conditions
- Dysodia
- Keywords
- Singers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- GIPSA-lab, Grenoble, France
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aerodynamic data : estimated subglottal pressure
Time frame: 1 day
estimated subglottal pressure (values in hPa)
Aerodynamic data : phonation pressure threshold
Time frame: 1 day
phonation pressure threshold (values in hPa)
Aerodynamic data : oral airflow rate
Time frame: 1 day
oral airflow rate (values in l/s).
9 secondary outcomes
social and medical data : age
Time frame: 1 day
social and medical data : sex
Time frame: 1 day
social and medical data : occupation
Time frame: 1 day
social and medical data : singing style
Time frame: 1 day
social and medical data : level of training
Time frame: 1 day
social and medical data : voice complaint
Time frame: 1 day
social and medical data : phoniatric diagnosis
Time frame: 1 day
social and medical data : tobacco consumption
Time frame: 1 day
social and medical data : voice treatment
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion BEAUD principal investigator
UH MONTPELLIER
1 site in 1 country: see every site and its status.
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.