NCT03413033

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

August 16, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

January 18, 2018

Last Update Submit

May 12, 2021

Conditions

Keywords

Semi-occluded vocal tractresonance tubestongue trillvoice therapy

Outcome Measures

Primary Outcomes (1)

  • Contact quotient (CQ)

    Improvement of vocal folds vibration pattern, demonstrated by a decrease of the mean CQ, measured with Electroglottography.

    1 hour

Study Arms (1)

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 tubeOther: Tongue trill

Interventions

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.

Group 1

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.

Group 1

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • No current or past history of voice disorders.
  • No current or past voice training or therapy.
  • Vocal use larger than 20 hours per week.

You may not qualify if:

  • Laryngeal pathology during execution of stroboscopy.
  • Flu-like symptoms during measures.
  • Trouble with execution of semi-occluded vocal tract exercises.
  • Allergy to electrodes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Nacional de Colombia

Bogotá, 111321, Colombia

Location

Study Officials

  • Luisa F Ángel Gordillo

    Universidad Nacional de Colombia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc Physiology Student

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 29, 2018

Study Start

August 16, 2018

Primary Completion

January 31, 2019

Study Completion

February 28, 2019

Last Updated

May 13, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations