NCT04107337

Brief 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 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.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

August 1, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

January 20, 2021

Status Verified

September 1, 2020

Enrollment Period

2.3 years

First QC Date

August 1, 2019

Last Update Submit

January 19, 2021

Conditions

Keywords

DysodiaSingersStrawEstimated subglottal pressureAerodynamic measurementsOral airflow

Outcome Measures

Primary Outcomes (2)

  • Aerodynamic data : estimated subglottal pressure

    Estimated subglottal pressure (values in hPa)

    before vocal exercices

  • Aerodynamic data : estimated subglottal pressure

    Estimated subglottal pressure (values in hPa)

    after vocal exercices

Secondary Outcomes (4)

  • Aerodynamic data : phonation pressure threshold

    before vocal exercices

  • Aerodynamic data : phonation pressure threshold

    after vocal exercices

  • Aerodynamic data : oral airflow rate

    before vocal exercices

  • Aerodynamic data : oral airflow rate

    after vocal exercices

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group (N=10): this group will conduct a vocal work session based on semi-occluded vocal-tract exercises with a straw.

Other: Vocal work session with straw exercises

Control group

OTHER

Control group (N=10): the second group acting as control group will perform a vocal work session based on open mouth exercices (vocalizations).

Other: Vocal work session with open mouth exercises

Interventions

* 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.

Experimental group

* 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.

Control group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gui de Chauliac Hospital

Montpellier, Herault, 34295, France

Location

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2019

First Posted

September 27, 2019

Study Start

September 1, 2020

Primary Completion

December 25, 2022

Study Completion

December 25, 2023

Last Updated

January 20, 2021

Record last verified: 2020-09

Locations