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DysodiaDYSODIENCT04107337

Effect of Vocal Exercises With Straw on Aerodynamic Parameters of Voice (Pressure, Flow) in Dysodic Singers With Nodules

A study testing Vocal work session with straw exercises and Vocal work session with open mouth exercises in people with Dysodia and Vocal Disorders, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 consultations; they present increased risk of developing voice disorders. The most common lesion found in singers is nodule. It comes from vocal straining characterized by the use of a pressed phonation mode, resulting in an increase subglottal pressure and a decrease flow… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Dysodia, Vocal Disorders
What is being tested?
Vocal work session with straw exercises and Vocal work session with open mouth exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteFrance
Study dates
1 Sep 2020to 25 Dec 2023
Phase
Interventional
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • be a singer
  • being female
  • be over 18
  • have a diagnosis of dysodia associated with vocal compelling behavior. This diagnosis is made by the investigative phoniatrist coordinator of the study during the phoniatric consultation.
  • have signed the written informed consent.
  • be affiliated or beneficiary of a social security scheme.

Who cannot join

  • have hearing problems
  • Persons deprived of their liberty, protected adults or vulnerable persons
  • Pregnant and / or lactating woman

Trial locations and contacts

1 site in 1 country.

France1 site
  • Gui de Chauliac Hospital

    Montpellier, Herault, 34295

Other trials in France

About this study

Official title: Randomized Study of the Effect of Vocal Exercises With Straw on Aerodynamic Parameters of Voice (Pressure, Flow) in Dysodic Singers With Nodules

Singers are over-represented in phoniatric consultations; they present increased risk of developing voice disorders. The most common lesion found in singers is nodule. It comes from vocal straining characterized by the use of a pressed phonation mode, resulting in an increase subglottal pressure and a decrease flow rate. Voice therapy aims to restore a more relaxed phonation. There is a growing interest in semi-occluded vocal tract exercises with a straw in therapy; they have positive effects, particularly in terms of aerodynamic parameters such as subglottal pressure and oral airflow. After these exercises, subglottal pressure decreases and oral airflow increases. In other words, patient adopts a more relaxed phonation mode. Several studies have investigated the effect of these straw exercises on dysphonic patients i.e. on speaking voice; no study to date has explored the effect of these exercises on dysodic subjects i.e. on singing voice.

The aim of this study is to evaluate the impact of straw exercises compared to open-mouth exercises on aerodynamic parameters in dysodic women singers with nodules.

Read the detailed description

Singers are over-represented in phoniatric consultations; 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 vocal change that makes them consult earlier than non-singers. In addition, their complaints are specific to singing voice.

In phoniatrics, at the CHU Gui de Chauliac in Montpellier, singers (amateurs and professionals) represent one third of phoniatric patients. 80% of them are diagnosed with dysodia. Dysodia refers to singing voice disorders, in the same way as dysphonia 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.

Prevalence of dysodia is higher among women. This vocal disorder is most often associated with laryngeal pathology. Nodular lesions are most common in singers as in general population. Nodules are the consequence of vocal straining, also known as vocal hyperfunction.

Singing means learning, more or less finely, depending on the level of training and singing style, coordination between breath, vocal fold vibrations and resonators, the so-called pneumo-phono-resonant adaptations. To have balanced phonation, singer must properly dose the air pressure he applies under his vocal folds, have a sufficient flow rate and adapt muscular tension of the vocal folds (neither too strain nor too loose). In this mode of phonation, voice resonates without difficulty. On the other hand, during vocal straining, singer will put too much subglottal pressure decreasing flow rate, which creates a laryngeal tightening and can eventually cause nodules. The pressure threshold required to initiate a sound (phonation pressure threshold) is then increased. Vocal gesture is therefore inappropriate and the voice becomes ineffective.

After diagnosis of dysodia and vocal assessment to identify the patient's difficulties, the patient is referred to speech-language pathologist for voice therapy. According to the vocal difficulties identified, speech therapist defines the therapeutic objectives that will be adapted to each patient and individualized according to the diagnosis, the singer's profile, but also his objectives and his investment. Voice therapy aims not only to prevent the onset or aggravation of vocal disturbances but also to remove or compensate for voice limitations by reconditioning vocal gesture to make it more effective. In the case of nodular lesions, voice therapy therefore aims to reduce vocal straining.

There is no specific therapeutic tool for singers. As in speaking voice, speech-language pathologist uses technical aids as well as indirect and direct therapies. The main technical aid proposed is amplification of voice with a microphone in the event of vocal misuse or abuse, i.e. when the vocal load is too high. Indirect therapy consists of giving vocal hygiene advice, in order to eliminate causes of voice disorder and to establish a vocal economy program with the patient. On the other hand, direct therapy consists in directly modifying vocal gesture through vocal exercises. This therapy is based on the premise that the subject has acquired an inappropriate vocal gesture that the therapist identifies and corrects through vocal exercices. Direct therapy is based on three successive steps: i) rehabilitation of respiratory gesture, ii) work on a vocal emission without associated tension, so as to eventually reduce laryngeal lesions, and iii) awareness of the role of resonance cavities.

Concerning work of vocal emission, to reduce vocal straining, many therapies are based on semi-occluded vocal tract exercises, also called physiological exercises. They include labial and lingual trills (lip and tongue vibration), nasal consonants, voiced fricative consonants, kazoo as well as tubes or straws. Straw exercises are the most reproducible due to the precise calibration of occlusion. Montpellier University Hospital is the national leader in the development of these straw exercises in France, with a particular focus on flow control during the exercises.

The purpose of these exercises is to teach the patient to use proper air pressure and flow while singing. Several studies are investigating effects of these straw exercises on aerodynamic parameters of subglottal pressure, phonation pressure threshold and oral airflow. It appears that:

  • straw exercises reduce estimated subglottal pressure. For non-singers, this is true after 15 minutes of exercises as well as after 8 rehabilitation sessions. For singers, results are more variable and concern only singers without voice disorders. No studies have explored effect of straw exercises on estimated subglottal pressure in dysodic singers.
  • straw exercises lower phonation threshold pressure (PTP). Most studies find a decrease in PTP after straw exercises, either in non-singer patients with speaking voice disorders or in choristers without voice disorders. No studies have explored effect of straw exercises on PTP in dysodic singers.
  • Literature does not provide information on impact of straw exercises on oral airflow. In euphonic subjects (without vocal disorder), whether singers or not, majority of studies find an increase in airflow after straw exercises. Only one study found no difference in airflow after straw exercises, while airflow increased after vocal exercises without straw (vocalized). In dysphonic patients, no difference in flow rate is observed after straw exercises. No studies have explored effect of straw exercises on airflow in dysodic singers.

Thus, no study to date has explored effect of straw exercises on aerodynamic parameters (estimated subglottal pressure, PTP, oral airflow) in dysodic singers. Singers are often targeted as a study population because of their familiarity with semi-occluded exercises but not to further explore singing voice. For example, in a study only one frequency is tested (pitch and comfortable intensity), so singing voice is not further explored. However, the economic and psychological impact of dysodia, particularly among professionals, is well described in the literature.

In this project the investigator want to fill this gap by studying the singing voice effect of straw exercises on the estimated subglottal pressure, PTP and oral airflow in dysodic women singers. Do straw vocal exercises modify aerodynamic behaviour of dysodic women singers with nodules after a rehabilitation session? Based on results of literature for speaking and singing non-pathological voice, the investigator hypothesize that the estimated subglottal pressure and PTP will decrease after straw exercise session while they will remain constant after open mouth exercise session. Meanwhile, the investigator hypothesize that oral airflow will increase following straw exercises while it will remain constant after open-mouth exercises.

Being tested
Vocal work session with straw exercises, Vocal work session with open mouth exercises
Keywords
Dysodia, Singers, Straw, Estimated subglottal pressure, Aerodynamic measurements, Oral airflow
Medical subject headings
Dysphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vocal work session with straw exercisesOther

    • Voice assessment: A questionnaire on the subject's voice biography will be sent to the subject at the moment of inclusion.
    • Vocal exercises during 10 minutes : (1 minute) Checking the posture ; (1 minute) Control of the management of breath in the straw ; (1 minute) Phonation in the straw ; (2 minutes) Make a siren in the straw ; (4 minutes) Vocalizations in the straw on the arpeggio of Rossini.

    This working session will be preceded and followed by the same 10-minutes voice assessment focusing on aerodynamic parameters.

  • Vocal work session with open mouth exercisesOther

    • Voice assessment: A questionnaire on the subject's voice biography will be sent to the subject at the moment of inclusion.
    • Vocal exercises during 10 minutes : (1 minute) Checking the posture ; (1 minute) Control of the management of breath on a [f] with open mouth ; (1 minute) Phonation on the vowel [a] with open mouth ; (2 minutes) Make a siren on the vowel [a] with open mouth ; (4 minutes) Vocalizations on the vowel [a] on the arpeggio of Rossini with open mouth.

    This working session will be preceded and followed by the same 10-minutes voice assessment focusing on aerodynamic parameters.

Study groups in NCT04107337
Study groupRoleWhat they receive
Experimental groupExperimentalExperimental group (N=10): this group will conduct a vocal work session based on semi-occluded vocal-tract exercises with a straw.
Receives: Other: Vocal work session with straw exercises
Control groupOtherControl group (N=10): the second group acting as control group will perform a vocal work session based on open mouth exercices (vocalizations).
Receives: Other: Vocal work session with open mouth exercises

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: before vocal exercices

  2. Aerodynamic data : estimated subglottal pressure

    Estimated subglottal pressure (values in hPa)

    Measured: after vocal exercices

Secondary outcomes (4)
  1. Aerodynamic data : phonation pressure threshold

    Phonation pressure threshold (values in hPa)

    Measured: before vocal exercices

  2. Aerodynamic data : phonation pressure threshold

    Phonation pressure threshold (values in hPa)

    Measured: after vocal exercices

  3. Aerodynamic data : oral airflow rate

    oral airflow rate (values in l/s)

    Measured: before vocal exercices

  4. Aerodynamic data : oral airflow rate

    oral airflow rate (values in l/s)

    Measured: after vocal exercices

Timeline

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

  1. First posted27 Sep 2019
  2. Study start1 Sep 2020
  3. Primary completion25 Dec 2022 (estimated)
  4. Study completion25 Dec 2023 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
1. Experimental group (N=10): vocal work session based on semi-occluded vocal-tract exercises with a straw. 2. Control group (N=10): the second group acting as control group will perform a vocal work session based on open mouth exercices (vocalizations).
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04107337
Sponsor's protocol ID
RECHMPL19_0262
Acronym
DYSODIE
Status last verified
Sep 2020
First submitted
1 Aug 2019
Last updated
20 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Vocal work session with straw exercises and Vocal work session with open mouth exercises in people with Dysodia and Vocal Disorders, 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 6 inclusion and 3 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 20 Jan 2021. 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: before vocal exercices). The study lists 2 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 20 Jan 2021.

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