Immediate Effects of Two Semi-occluded Vocal Tract Exercises

May 12, 2021 updated by: Andres Fernando Delprado, Universidad Nacional de Colombia

Immediate Effects of Two Semi-occluded Vocal Tract Exercises on Laryngeal Activity of Individuals With Constant Vocal Effort

This study aims to observe the physiological effects of two different Semi-occluded vocal tract (SOVT) exercises in the larynx when they are executed by individuals with constant vocal effort and without vocal pathology.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogotá, Colombia, 111321
        • Universidad Nacional de Colombia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Healthy university teachers despite constant vocal effort, without past voice training or therapy.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Resonance tube
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.
Other: Tongue trill
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Nacional de Colombia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Luisa F Ángel Gordillo, Universidad Nacional de Colombia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 012-210-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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