- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413033
Immediate Effects of Two Semi-occluded Vocal Tract Exercises
Immediate Effects of Two Semi-occluded Vocal Tract Exercises on Laryngeal Activity of Individuals With Constant Vocal Effort
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SOVT is a voice education or rehabilitation method that involves different postures which partially occlude or elongate the vocal tract. It causes a change in the vibration pattern of the vocal folds. SOVT postures have been postulated to produce changes in contact quotient (CQ), measured with electroglottograph (EGG). This study aims to observe the physiological effects of two different SOVT exercises in larynx when they are executed by people with constant vocal effort and without vocal pathology. In order to do so, EGG will be performed before and after 43 volunteers execute two SOVT exercises (tongue trill and resonance tubes). The following parameter will be captured: CQ. A t-paired test will be performed to compare pre and post-test information. Furthermore, a generalized estimating equation will be fit to find the effects of each exercise in the subjects.
This protocol was modified due to different administrative issues related to the use of the stroboscopy (one of the assesment tools previosly considered), so that stroboscopy was removed from the protocol.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
-
Bogotá, Colombia, 111321
- Universidad Nacional de Colombia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- No current or past history of voice disorders.
- No current or past voice training or therapy.
- Vocal use larger than 20 hours per week.
Exclusion Criteria:
- Laryngeal pathology during execution of stroboscopy.
- Flu-like symptoms during measures.
- Trouble with execution of semi-occluded vocal tract exercises.
- Allergy to electrodes.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
43 participants will produce the vowel /a:/ three times as baseline during 5 seconds in habitual, comfortable speaking pitch and loudness.
Thereafter, participants will produce series of a semi-occluded vocal tract exercises (resonance tube or lip trill).
Afterwards, subjects will produce the vowel /a:/ three times once again.
Electroglottographic signals will be captured before and after each exercise.
A 15 minutes voice rest will be taken between exercises by all subjects.
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Participants will phonate into a tube (10cm length 4mm inner diameter) during 5 minutes.
They will produce series of the vowel /u/ into the tube.
They will be asked to maintain the same pitch and loudness as they did in the baseline samples.
They will be perceptually controlled by experimenters.
When performing the exercise, the participants will be instructed to phonate with ease voice and to sense vibrations in the anterior face and the mouth.
Participants will produce series of a similar /r/ Spanish sound during 5 minutes.
They will be asked to maintain the same pitch and loudness as they did in the baseline samples.
They will be perceptually controlled by experimenters.
When performing the exercise, the participants will be instructed to phonate with ease voice and to sense vibrations in the anterior face and the mouth.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Contact quotient (CQ)
Time Frame: 1 hour
|
Improvement of vocal folds vibration pattern, demonstrated by a decrease of the mean CQ, measured with Electroglottography.
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Luisa F Ángel Gordillo, Universidad Nacional de Colombia
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 012-210-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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