VoiceNCT03413033
Immediate Effects of Two Semi-occluded Vocal Tract Exercises
An observational study of Voice, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Voice
- What is being tested?
- Resonance tube and Tongue trill
- How many people
- 43 participants
- Where
- 1 siteColombia
- Study dates
- 16 Aug 2018to 28 Feb 2019
- Phase
- Observational
- 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 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy university teachers despite constant vocal effort, without past voice training or therapy.
Who may be able to join
- No current or past history of voice disorders.
- No current or past voice training or therapy.
- Vocal use larger than 20 hours per week.
Who cannot join
- Laryngeal pathology during execution of stroboscopy.
- Flu-like symptoms during measures.
- Trouble with execution of semi-occluded vocal tract exercises.
- Allergy to electrodes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Voice
- Being tested
- Resonance tube, Tongue trill
- Keywords
- Semi-occluded vocal tract, resonance tubes, tongue trill, voice therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonance tubeOther
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.
Tongue trillOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Resonance tube; Other: Tongue trill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact quotient (CQ)
Improvement of vocal folds vibration pattern, demonstrated by a decrease of the mean CQ, measured with Electroglottography.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start16 Aug 2018
- Primary completion31 Jan 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VoiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Fernando Delprado, Universidad Nacional de Colombia
- Investigators
- Luisa F Ángel Gordillo, Study director, Universidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413033
- Sponsor's protocol ID
- 012-210-18
- Status last verified
- May 2021
- First submitted
- 18 Jan 2018
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Two Semi-occluded Vocal Tract Exercises on Laryngeal Activity of Individuals With Constant Vocal Effort
- ClinicalTrials.gov ID
- NCT03413033
- Acronym / sponsor ID
- 012-210-18
- Conditions
- Voice
- Keywords
- Semi-occluded vocal tract, resonance tubes, tongue trill, voice therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Resonance tube, Other: Tongue trill43 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy university teachers despite constant vocal effort, without past voice training or therapy.
Key inclusion criteria (3 listed)
- No current or past history of voice disorders.
- No current or past voice training or therapy.
- Vocal use larger than 20 hours per week.
Key exclusion criteria (4 listed)
- Laryngeal pathology during execution of stroboscopy.
- Flu-like symptoms during measures.
- Trouble with execution of semi-occluded vocal tract exercises.
- Allergy to electrodes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resonance tubeParticipants 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 | Group 1 |
| Tongue trillParticipants 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. | Other | Group 1 |
Primary outcome
Contact quotient (CQ)
Time frame: 1 hour
Improvement of vocal folds vibration pattern, demonstrated by a decrease of the mean CQ, measured with Electroglottography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luisa F Ángel Gordillo study director
Universidad Nacional de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voice, run by Universidad Nacional de Colombia at 1 site in Colombia.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 May 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Contact quotient (CQ) (time frame: 1 hour). 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 13 May 2021; AzTrials last refreshed its copy on 6 Nov 2026.