Mid-membranous Vocal Fold LesionNCT06165536
Laryngeal and Vocal Tract Strategies to Reduce Vocal Fold Contact Pressure
A study testing Resonant voice therapy in people with Mid-membranous Vocal Fold Lesion, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Phonotraumatic vocal hyperfunction is one of the most frequently occurring conditions to affect the voice. This voice disorder often involves vocal fold injury due to repeated, excessive contact pressure between the vocal folds when they collide during voice production. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mid-membranous Vocal Fold Lesion
- What is being tested?
- Resonant voice therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18-40 years (to minimize developmental changes associated with adolescent and elderly age)
- Clinic diagnosis by a fellowship trained laryngologist of mid-membranous lesions that by history and appearance are phonotraumatic
- Must be referred for voice therapy
Who cannot join
- Medical comorbidities (e.g., autoimmune disorders) beyond seasonal allergy and laryngopharyngeal reflux
- Vocal fold lesions generally regarded to be less responsive to voice therapy (e.g. vocal fold cysts).
- Claustrophobia
- Inability to replicate fundamental frequencies required for the study at the intensity levels determined
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA Rehab Center
Los Angeles, California, 90095
Zhaoyan Zhang, 310-206-4324
Zhaoyan Zhang
About this study
Phonotraumatic vocal hyperfunction is one of the most frequently occurring conditions to affect the voice. This voice disorder often involves vocal fold injury due to repeated, excessive contact pressure between the vocal folds when they collide during voice production. In the clinic, voice therapy attempts to modify unhealthy vocal behaviors through different techniques or exercises. While voice therapy is generally considered effective, the scientific rationale for its therapeutic benefits still remains unclear. It is generally believed that these exercises lead to adjustments in the larynx and vocal tract that reduce vocal fold contact pressure. However, this assumption has never been tested in humans or laboratory experiments. The goal of this clinical trial is to investigate the effectiveness of voice therapy in reducing vocal fold contact pressures and in eliciting the hypothesized favorable laryngeal and vocal tract configurations.
Read the detailed description
This study will investigate the degree to which a well-documented voice therapy technique, resonant voice therapy, reduces vocal fold contact pressure compared to baseline, and which if any laryngeal and vocal tract adjustments occur in association with this phonation pattern. The investigators will measure contact pressure in vivo in human subjects, and will use computed tomography scans to assess laryngeal and vocal tract configurations before and after initial voice training, in adults with phonotraumatic lesions. The investigators will correlate these measures to patient-reported outcome measures and other secondary outcome measures across longer-term therapy. It is hypothesized that findings regarding favorable physical adjustments associated with reduction in contact pressure shown in this aim will match those identified in our recent simulation studies, and that initial reduction in contact pressure in resonant voice, associated with relevant perceptual, acoustic, and subglottic pressure changes, will correlate with improved long-term voice therapy outcome.
Patients will be those who have been diagnosed by a fellowship trained laryngologist with bilateral mid-membranous lesions that by appearance and history are phonotraumatic and who are referred to resonant voice therapy (RVT). Each subject will receive resonant voice therapy, a standard of care procedure for treating phonotraumatic vocal hyperfunction. The full standardized voice therapy program will have a duration of four weeks, each week with one 60-minute therapy session. All voice therapy sessions will be video recorded. Ten percent of recordings will be randomly selected and used in fidelity checks. Data collection will take place at 3 time points: before therapy (baseline), immediately after an initial therapy session, and after 4 weeks of therapy. At baseline, each subject will fill out a Voice Handicap Index-10 (VHI-10) questionnaire, and will receive videoendoscopic examination, CT scans of the head and neck region during phonation, acoustic and subglottal pressure measurement, and contact pressure measurement. Data collection will be repeated the same day following an initial session of RVT training. Same-day data collection will ensure that lesion characteristics have not changed from baseline, and avoid confounding effects of lesion change in contact pressure measures. Degree of resonant voice acquisition will be determined by speech language pathologists (SLPs) real-time and will be further characterized quantitatively by post hoc perceptual evaluation and acoustic measures. Finally, after 4 weeks of RVT, follow-up measure will include VHI-10, endoscopic exam, perceptual, acoustic, and subglottal pressure measurement.
- Conditions
- Mid-membranous Vocal Fold Lesion
- Being tested
- Resonant voice therapy
- Keywords
- Vocal fold lesion, Vocal hyperfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonant voice therapyBehavioural
Resonant voice therapy is a standard of care procedure for treating phonotraumatic vocal hyperfunction. The full standardized voice therapy program will have a duration of four weeks, each week with one 60-minute therapy session.
| Study group | Role | What they receive |
|---|---|---|
| Voice therapy | Other | Resonant voice therapy is a standard of care procedure for treating phonotraumatic vocal hyperfunction. The full standardized voice therapy program will have a duration of four weeks, each week with one 60-minute therapy session. Receives: Behavioral: Resonant voice therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice handicap index (VHI-10)
VHI-10 scores will be measured using the voice handicap index-10 questionnaire. Scores for the VHI-10 range from 0 to 40, with higher scores indicating a greater voice-related handicap.
Measured: 30 minutes before the first voice therapy session, and 30 minutes after the last session of the 4-week voice therapy
Severity of vocal fold lesions
The medical severity of vocal fold lesions will be rated based on videoendoscopic examination of the larynx. The Nuss scale - a vetted, widely clinically used visual-perceptual scale - will be used to rate presence/absence of nodules (0) and nodules size (1 = small, 2 = moderate, 3 = large). Higher scores indicate worse outcomes.
Measured: 30 minutes before the first voice therapy session, and 30 minutes after the last session of the 4-week voice therapy
Secondary outcomes (1)
Perceptual evaluation of voice
Perceptual evaluation will be conducted on the recorded phrase, "We were away a year ago," using the Overall Severity scale from the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V), using pre-post therapy paired comparison procedures. Scores will range between 0 and 100, with higher scores indicating worse outcomes. Raters will be five blinded voice-specialized speech language pathologists otherwise not involved with the study.
Measured: Perceptual evaluation will be performed within 6 months of data collection, using voices recorded 30 minutes before and 30 minutes after the first voice therapy session and 30 minutes after the last session of the 4-week voice therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Dec 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid-membranous Vocal Fold LesionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Zhaoyan Zhang, PhD, University of California, Los Angeles
- Investigators
- Zhaoyan Zhang, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165536
- Sponsor's protocol ID
- 22-001058
- Other IDs
- R01DC020240
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected during this project, including acoustic, aerodynamic, vocal fold geometry data from medial surface imaging or CT scans, vocal fold contact pressure, will be archived and made available to interested investigators on request after the investigators have finished planned analyses and publications.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal and Vocal Tract Strategies to Reduce Vocal Fold Contact Pressure
- ClinicalTrials.gov ID
- NCT06165536
- Acronym / sponsor ID
- 22-001058
- Conditions
- Mid-membranous Vocal Fold Lesion
- Keywords
- Vocal fold lesion, Vocal hyperfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 11 Dec 2023 (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.
Phonotraumatic vocal hyperfunction is one of the most frequently occurring conditions to affect the voice. This voice disorder often involves vocal fold injury due to repeated, excessive contact pressure between the vocal folds when they collide during voice production. In the clinic, voice therapy attempts to modify unhealthy vocal behaviors through different techniques or exercises. While voice therapy is generally considered effective, the scientific rationale for its therapeutic benefits still remains unclear. It is generally believed that these exercises lead to adjustments in the larynx and vocal tract that reduce vocal fold contact pressure. However, this assumption has never been tested in humans or laboratory experiments. The goal of this clinical trial is to investigate the effectiveness of voice therapy in reducing vocal fold contact pressures and in eliciting the hypothesized favorable laryngeal and vocal tract configurations.
Detailed description
This study will investigate the degree to which a well-documented voice therapy technique, resonant voice therapy, reduces vocal fold contact pressure compared to baseline, and which if any laryngeal and vocal tract adjustments occur in association with this phonation pattern. The investigators will measure contact pressure in vivo in human subjects, and will use computed tomography scans to assess laryngeal and vocal tract configurations before and after initial voice training, in adults with phonotraumatic lesions. The investigators will correlate these measures to patient-reported outcome measures and other secondary outcome measures across longer-term therapy. It is hypothesized that findings regarding favorable physical adjustments associated with reduction in contact pressure shown in this aim will match those identified in our recent simulation studies, and that initial reduction in contact pressure in resonant voice, associated with relevant perceptual, acoustic, and subglottic pressure changes, will correlate with improved long-term voice therapy outcome.
Patients will be those who have been diagnosed by a fellowship trained laryngologist with bilateral mid-membranous lesions that by appearance and history are phonotraumatic and who are referred to resonant voice therapy (RVT). Each subject will receive resonant voice therapy, a standard of care procedure for treating phonotraumatic vocal hyperfunction. The full standardized voice therapy program will have a duration of four weeks, each week with one 60-minute therapy session. All voice therapy sessions will be video recorded. Ten percent of recordings will be randomly selected and used in fidelity checks. Data collection will take place at 3 time points: before therapy (baseline), immediately after an initial therapy session, and after 4 weeks of therapy. At baseline, each subject will fill out a Voice Handicap Index-10 (VHI-10) questionnaire, and will receive videoendoscopic examination, CT scans of the head and neck region during phonation, acoustic and subglottal pressure measurement, and contact pressure measurement. Data collection will be repeated the same day following an initial session of RVT training. Same-day data collection will ensure that lesion characteristics have not changed from baseline, and avoid confounding effects of lesion change in contact pressure measures. Degree of resonant voice acquisition will be determined by speech language pathologists (SLPs) real-time and will be further characterized quantitatively by post hoc perceptual evaluation and acoustic measures. Finally, after 4 weeks of RVT, follow-up measure will include VHI-10, endoscopic exam, perceptual, acoustic, and subglottal pressure measurement.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voice therapy | Other | Behavioral: Resonant voice therapyResonant voice therapy is a standard of care procedure for treating phonotraumatic vocal hyperfunction. The full standardized voice therapy program will have a duration of four weeks, each week with one 60-minute therapy session. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18-40 years (to minimize developmental changes associated with adolescent and elderly age)
- Clinic diagnosis by a fellowship trained laryngologist of mid-membranous lesions that by history and appearance are phonotraumatic
- Must be referred for voice therapy
Key exclusion criteria (4 listed)
- Medical comorbidities (e.g., autoimmune disorders) beyond seasonal allergy and laryngopharyngeal reflux
- Vocal fold lesions generally regarded to be less responsive to voice therapy (e.g. vocal fold cysts).
- Claustrophobia
- Inability to replicate fundamental frequencies required for the study at the intensity levels determined
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 |
|---|---|---|
| Resonant voice therapyResonant voice therapy is a standard of care procedure for treating phonotraumatic vocal hyperfunction. The full standardized voice therapy program will have a duration of four weeks, each week with one 60-minute therapy session. | Behavioural | Voice therapy |
Primary outcome
Voice handicap index (VHI-10)
Time frame: 30 minutes before the first voice therapy session, and 30 minutes after the last session of the 4-week voice therapy
VHI-10 scores will be measured using the voice handicap index-10 questionnaire. Scores for the VHI-10 range from 0 to 40, with higher scores indicating a greater voice-related handicap.
Severity of vocal fold lesions
Time frame: 30 minutes before the first voice therapy session, and 30 minutes after the last session of the 4-week voice therapy
The medical severity of vocal fold lesions will be rated based on videoendoscopic examination of the larynx. The Nuss scale - a vetted, widely clinically used visual-perceptual scale - will be used to rate presence/absence of nodules (0) and nodules size (1 = small, 2 = moderate, 3 = large). Higher scores indicate worse outcomes.
1 secondary outcome
Perceptual evaluation of voice
Time frame: Perceptual evaluation will be performed within 6 months of data collection, using voices recorded 30 minutes before and 30 minutes after the first voice therapy session and 30 minutes after the last session of the 4-week voice therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Yes. All data collected during this project, including acoustic, aerodynamic, vocal fold geometry data from medial surface imaging or CT scans, vocal fold contact pressure, will be archived and made available to interested investigators on request after the investigators have finished planned analyses and publications.
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.
Zhaoyan Zhang principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resonant voice therapy in people with Mid-membranous Vocal Fold Lesion, run by University of California, Los Angeles at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaoyan Zhang (3102064324, zyzhang@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice handicap index (VHI-10) (time frame: 30 minutes before the first voice therapy session, and 30 minutes after the last session of the 4-week voice therapy). 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?
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 15 Dec 2025.