Voice DisordersNCT06137131

Voice Therapy With a Semi-occluded Vocal Tract

A study testing Straw phonation in air, straw phonation in water and /u/ phonation in people with Voice Disorders, run by University Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. The first objective of this research is to investigate the immediate effects of three semi-occluded vocal tract (SOVT) exercises (straw phonation in air, straw phonation in 2cm water, and straw phonation in 5cm water) on (supra)glottic activity of vocally healthy participants and patients with voice disorders… Read more about this study

Who is it for?: Ages 17 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Voice Disorders
What is being tested?: Straw phonation in air, straw phonation in water and /u/ phonation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteBelgium
Study dates: 7 Oct 2021to 14 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 to 50 years
All sexes
Healthy volunteers accepted
Child, Adult

Patients:

Inclusion criteria are aged between 17 and 50 years, and diagnosed with dysphonia by an otorhinolaryngologist and SLP experienced in voice diagnostics. Exclusion criteria are previous or current participation in voice therapy, previous phonosurgical interventions, pregnancy, smoking, nasal or ear diseases, and neurological disorders.

Vocally healthy participants:

Inclusion criteria are aged between 17 and 50 years. Exclusion criteria are dagnosed with dysphonia, previous or current participation in voice therapy, previous phonosurgical interventions, pregnancy, smoking, nasal or ear diseases, and neurological disorders.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Department of Rehabilitation Sciences, Ghent University (Hospital)
Ghent, East-Flanders, 9000

Other trials in Belgium

About this study

Official title: Voice Therapy With a Semi-occluded Vocal Tract: From Current Challenges to Next Level Efficacy Studies

The first objective of this research is to investigate the immediate effects of three semi-occluded vocal tract (SOVT) exercises (straw phonation in air, straw phonation in 2cm water, and straw phonation in 5cm water) on (supra)glottic activity of vocally healthy participants and patients with voice disorders (dysphonia) visualized with laryngovideostroboscopy. Participants will receive a flexible laryngovideostroboscopy, both during normal phonation and during the specific SOVT exercise. These videos will be randomly and blindly evaluated by two experts using the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017). Researchers will compare the effects of these SOVT exercises on the (supra)glottic activity with the effects found in a control group producing /u/ phonation, using a randomized controlled trial.
The second objective of this research is to investigate the short- and long-term effects of the three SOVT therapy approaches on the (supra)glottic activity, voice quality and self-report of patients with voice disorders (dysphonia).

Participants will receive a short-term intensive therapy with the specific SOVT exercise across four weeks.

Immediately after the therapy program and at 1 and 3 months follow-up, the voice of the participants will be re-evaluated.

Conditions: Voice Disorders
Being tested: Straw phonation in air, straw phonation in water, /u/ phonation
Keywords: voice, semi-occluded vocal tract, larynx, randomized controlled trial, efficacy study
Medical subject headings: Voice Disorders, Laryngeal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Straw phonation in airBehavioural
Also called steady SOVT exercise
Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
straw phonation in waterBehavioural
Also called water-resistance therapy, fluctuating SOVT exercise
Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
/u/ phonationBehavioural
Also called articulatory/steady SOVT exercise
/u/ phonation without a straw, control condition

Study groups in NCT06137131
Study group	Role	What they receive
straw phonation in air	Experimental	Participants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset. Receives: Behavioral: Straw phonation in air
straw phonation in 2 cm water	Experimental	Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 2 cm below the water surface, with slightly pursed lips and a soft voice onset. Receives: Behavioral: straw phonation in water
straw phonation in 5 cm water	Experimental	Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 5 cm below the water surface, with slightly pursed lips and a soft voice onset. Receives: Behavioral: straw phonation in water
/u/ control condition	Active comparator	Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw. Receives: Behavioral: /u/ phonation

What is being measured

The primary outcome is the main question the study is designed to answer.

(Supra)Glottic Activity: Amplitude of Vibration
Laryngeal function determined with the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017).
Amplitude of vibration: magnitude of lateral movement of the vocal folds. This is a visual-perceptual evaluation based on the video samples of the strobovideolaryngoscopy. Raters score the magnitude of lateral movement of the vocal folds based on the graphic of the VALI form ranging from 0 to 10, this number is then multiplied by 10 to obtain a percentage. Lower percentages mean a smaller amplitude of vibration, higher percentages mean a larger amplitude of vibration.
Measured: baseline (before the intervention)
Supraglottic Activity: Anteroposterior Compression
Laryngeal function determined with the VALI form (Poburka et al, 2017).
Anteroposterior supraglottic compression: constriction of the supraglottic structures in the anteroposterior dimension. This is a visual-perceptual evaluation based on the video samples of the strobovideolaryngoscopy. Raters score the supraglottic compression based on the graphic of the VALI form on a scale ranging from 0 to 5 (with the aid of concentric circles). The higher the number, the more supraglottic compression. More supraglottic compression is often seen as a negative outcome, however it might be a beneficial effect seen in SOVT phonation studied here.
Measured: baseline (before the intervention)

Secondary outcomes (5)

Voice Quality Index 1: Dysphonia Severity Index (DSI)
DSI: A higher index indicates a better voice quality. The index ranges from -5 to +5 for severely dysphonic to normal voices. A more negative index indicates a worse voice quality. Values > +5 are possible in subjects with excellent vocal capacities. A DSI = +1.6 is the threshold separating normophonic from dysphonic persons.
Measured: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Voice Quality Index 2: Acoustic Voice Quality Index (AVQI)
A lower AVQI indicates a better voice quality. The index ranges from 0 to 10 for normal to severely dysphonic voices. An AVQI of 2.95 is the threshold separating normophonic from dysphonic persons.
Measured: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Self-report 1: Voice Handicap Index (VHI)
VHI: A lower index indicates less impact of the voice impairment on the quality of life. The VHI ranges from 0 to 120.
Measured: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Self-report 2: Vocal Tract Discomfort Scale (VTDS)
VTDS: A lower index indicates less discomfort in the vocal tract. The index ranges from 0 to 96.
Measured: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Self-report 3: Vocal Fatigue Index (VFI)
VFI: A lower index indicates less vocal fatigue. The index ranges from 0 to 76.
Measured: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 202114 Mar 2023

First posted18 Nov 2023
Study start7 Oct 2021
Primary completion14 Mar 2023
Study completion14 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Voice DisordersStudies of the same condition, open and under way.
More trials run by University GhentThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06137131
Sponsor's protocol ID: 249721N
Status last verified: Aug 2024
First submitted: 20 Oct 2023
Last updated: 30 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Voice Therapy With a Semi-occluded Vocal Tract: From Current Challenges to Next Level Efficacy Studies
ClinicalTrials.gov ID: NCT06137131
Acronym / sponsor ID: 249721N
Conditions: Voice Disorders
Keywords: voice, semi-occluded vocal tract, larynx, randomized controlled trial, efficacy study
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: University GhentUniversity, hospital or other
Collaborators: Research Foundation Flanders
Study start: 7 Oct 2021 (actual)
Primary completion: 14 Mar 2023 (actual)
Study completion: 14 Mar 2023 (actual)
First posted: 18 Nov 2023 (actual)
Results: Posted 30 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The first objective of this research is to investigate the immediate effects of three semi-occluded vocal tract (SOVT) exercises (straw phonation in air, straw phonation in 2cm water, and straw phonation in 5cm water) on (supra)glottic activity of vocally healthy participants and patients with voice disorders (dysphonia) visualized with laryngovideostroboscopy. Participants will receive a flexible laryngovideostroboscopy, both during normal phonation and during the specific SOVT exercise. These videos will be randomly and blindly evaluated by two experts using the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017). Researchers will compare the effects of these SOVT exercises on the (supra)glottic activity with the effects found in a control group producing /u/ phonation, using a randomized controlled trial.
The second objective of this research is to investigate the short- and long-term effects of the three SOVT therapy approaches on the (supra)glottic activity, voice quality and self-report of patients with voice disorders (dysphonia).

Participants will receive a short-term intensive therapy with the specific SOVT exercise across four weeks.

Immediately after the therapy program and at 1 and 3 months follow-up, the voice of the participants will be re-evaluated.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
straw phonation in air	Experimental	Behavioral: Straw phonation in airParticipants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset.
straw phonation in 2 cm water	Experimental	Behavioral: straw phonation in waterParticipants will be asked to phonate an /u/ vowel through a stirring straw, placed 2 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in 5 cm water	Experimental	Behavioral: straw phonation in waterParticipants will be asked to phonate an /u/ vowel through a stirring straw, placed 5 cm below the water surface, with slightly pursed lips and a soft voice onset.
/u/ control condition	Active comparator	Behavioral: /u/ phonationParticipants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw.

Who may qualify

Ages: 17 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

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
Straw phonation in airAlso: steady SOVT exercisePhonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air	Behavioural	straw phonation in air
straw phonation in waterAlso: water-resistance therapy, fluctuating SOVT exercisePhonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water	Behavioural	straw phonation in 2 cm water, straw phonation in 5 cm water
/u/ phonationAlso: articulatory/steady SOVT exercise/u/ phonation without a straw, control condition	Behavioural	/u/ control condition

Primary outcome

(Supra)Glottic Activity: Amplitude of Vibration
Time frame: baseline (before the intervention)
Laryngeal function determined with the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017). Amplitude of vibration: magnitude of lateral movement of the vocal folds. This is a visual-perceptual evaluation based on the video samples of the strobovideolaryngoscopy. Raters score the magnitude of lateral movement of the vocal folds based on the graphic of the VALI form ranging from 0 to 10, this number is then multiplied by 10 to obtain a percentage. Lower percentages mean a smaller amplitude of vibration, higher percentages mean a larger amplitude of vibration.
Supraglottic Activity: Anteroposterior Compression
Time frame: baseline (before the intervention)
Laryngeal function determined with the VALI form (Poburka et al, 2017). Anteroposterior supraglottic compression: constriction of the supraglottic structures in the anteroposterior dimension. This is a visual-perceptual evaluation based on the video samples of the strobovideolaryngoscopy. Raters score the supraglottic compression based on the graphic of the VALI form on a scale ranging from 0 to 5 (with the aid of concentric circles). The higher the number, the more supraglottic compression. More supraglottic compression is often seen as a negative outcome, however it might be a beneficial effect seen in SOVT phonation studied here.

5 secondary outcomes

Voice Quality Index 1: Dysphonia Severity Index (DSI)
Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Voice Quality Index 2: Acoustic Voice Quality Index (AVQI)
Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Self-report 1: Voice Handicap Index (VHI)
Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Self-report 2: Vocal Tract Discomfort Scale (VTDS)
Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Self-report 3: Vocal Fatigue Index (VFI)
Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up

Results and safety

Results posted to the registry on 30 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Straw Phonation in Air	15	14
Straw Phonation in 2 cm Water	15	13
Straw Phonation in 5 cm Water	14	13
/u/ Control Condition	14	12

Primary outcome: (Supra)Glottic Activity: Amplitude of Vibration

Time frame: baseline (before the intervention). Mean (Inter-Quartile Range). Unit: percentage

Measure	Straw Phonation in Air n = 14	Straw Phonation in 2 cm Water n = 13	Straw Phonation in 5 cm Water n = 13	/u/ Control Condition n = 12
SOVT phonation	37.7 (33.6 to 41.7)	32.5 (28.0 to 37.0)	28.8 (24.5 to 33.2)	37.1 (32.6 to 41.6)
habitual phonation	36.7 (32.6 to 40.7)	39.6 (35.1 to 44.1)	40.0 (35.6 to 44.4)	34.6 (30.1 to 39.1)

Primary outcome: Supraglottic Activity: Anteroposterior Compression

Time frame: baseline (before the intervention). Mean (Inter-Quartile Range). Unit: units on a scale

Measure	Straw Phonation in Air n = 14	Straw Phonation in 2 cm Water n = 13	Straw Phonation in 5 cm Water n = 13	/u/ Control Condition n = 12
SOVT phonation	2.6 (1.9 to 3.3)	2.3 (1.4 to 3.1)	2.9 (2.1 to 3.7)	1.3 (0.4 to 2.1)
habitual phonation	1.2 (0.5 to 1.9)	1.0 (0.2 to 1.8)	1.4 (0.7 to 2.2)	1.4 (0.7 to 2.3)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Straw Phonation in Air	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Straw Phonation in 2 cm Water	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Straw Phonation in 5 cm Water	0 of 13 (0%)	0 of 13 (0%)	0 of 13
/u/ Control Condition	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Kristiane Van Lierde, PhD principal investigator

University Ghent

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Straw phonation in air, straw phonation in water and /u/ phonation in people with Voice Disorders, run by University Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 30 Oct 2024. 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 Belgium. 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?

Yes. Results are posted in the registry (first posted 30 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

(Supra)Glottic Activity: Amplitude of Vibration (time frame: baseline (before the intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06137131.

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 30 Oct 2024.