DysphoniaPhase 3NCT07145086
Translaryngeal Vibration for Hyperfunctional Voice Disorders
A Phase 3 study testing Voice therapy with vibration in people with Dysphonia and Muscle Tension Dysphonia, run by Texas Christian University at 1 site in United States.
Trial summary
Contemporary treatments for hyperfunctional voice disorders such as muscle tension dysphonia (MTD) are effective but typically do not restore voice handicap or voice function to normal thresholds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphonia, Muscle Tension Dysphonia
- What is being tested?
- Voice therapy with vibration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 31 Aug 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a) diagnosis by an otolaryngologist of hyperfunctional dysphonia (MTD) without benign mid-membranous lesion (i.e., primary MTD or non-phonotraumatic hyperfunction) with and a recommendation for voice therapy, ((b) confirmation of dysphonia by a comprehensive voice evaluation conducted by a speech-language pathologist with experience in the evaluation and treatment of voice disordered populations, (c) to prevent floor effects of our primary outcome variable, participants will be required to exhibit a pre-treatment VHI score of >20, as this is the upper range for normal cutoff values in studies which have demonstrated high sensitivity and specificity for this tool (Behlau et al., 2016), (d) 18 years of age or older, (e) no history of local vibration therapy as part of a rehabilitation treatment program.
Who cannot join
- Unable to receive vibration to neck area
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
Texas Christian University
Fort Worth, Texas, 76109
Christopher R Watts, Ph.D., 817-257-6878, c.watts@tcu.edu
Christopher R Watts, Ph.D.
About this study
Contemporary treatments for hyperfunctional voice disorders such as muscle tension dysphonia (MTD) are effective but typically do not restore voice handicap or voice function to normal thresholds. Recent reports of vibration as a voice therapy modality have been published, but many questions remain about the efficacy of this tool. The current project addresses these problems through a blinded and randomized controlled trial to investigate the efficacy of local translaryngeal vibration for MTD and the dose-response relationship of this modality when compared to treatment without vibration.
Read the detailed description
High-quality research designs have demonstrated that voice therapy has a positive impact on hyperfunctional voice disorders associated with muscle tension dysphonia (MTD). Among the options of behavioral voice therapy for MTD, one of the most effective evidence-based approaches is flow phonation (a.k.a., stretch-and-flow voice therapy). However, the phenomenon of post-treatment outcome measures remaining substantially outside the range of normal is a ubiquitous finding in studies investigating this and other voice therapy approaches. From both a cost burden and quality of life perspective, this phenomenon supports a need to develop and refine voice therapy treatment approaches to promote better outcomes. Vibration is a physical modality that has a historical use in the rehabilitation professions, but only recently has it been scientifically studied as a modality for voice therapy when used by speech-language pathologists. When applied locally on the perilaryngeal surface as a local translaryngeal vibration therapy (LTLV), early research has demonstrated beneficial effects on voice physiology and clinical outcomes. Further high-quality clinical research studies are needed to evaluate the efficacy of LTLV as a modality for voice disorders and to better understand the effects of vibration and effective vibration dose on voice rehabilitation outcomes. The research proposed in this R15 has the potential to transform clinical practice of treatment for MTD, the most common voice disorder among treatment-seeking populations. That potential is vested in the pursuit of three specific aims: (1) determine the clinical efficacy of LTLV as a concurrent treatment using flow phonation voice therapy in patients with MTD, and (2) determine the effect of treatment dose on clinical response associated with treatment outcomes. In addition to the potential impact of this R15, the innovative of approach of using LTLV as a concurrent modality with flow phonation combined with investigation of the most effective frequency parameter for clinical application represents a pioneering approach to advance the field of clinical voice practice in speech-language pathology.
- Conditions
- Dysphonia, Muscle Tension Dysphonia
- Being tested
- Voice therapy with vibration
- Keywords
- Dysphonia, Muscle Tension Dysphonia, Voice Therapy, Vibration
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice therapy with vibrationBehavioural
Voice therapy with a novel vibration device will be delivered for five or eight weeks depending on group allocation. All participants will receive flow phonation voice therapy.
| Study group | Role | What they receive |
|---|---|---|
| Five Week Therapy | Experimental | Participants receive five weeks of voice therapy with vibration Receives: Behavioral: Voice therapy with vibration |
| Eight Week Therapy | Active comparator | Participants receive eight weeks of voice therapy with vibration Receives: Behavioral: Voice therapy with vibration |
| Voice Therapy with Placebo | Placebo comparator | Participants receive eight weeks of voice therapy with vibration placebo Receives: Behavioral: Voice therapy with vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice Handicap Index
The Voice Handicap Index (VHI) is a self-assessment tool used to evaluate how a voice disorder impacts a person's daily life, encompassing functional, physical, and emotional aspects. It helps quantify the perceived handicap caused by a voice problem, aiding in diagnosis, treatment planning, and assessing treatment effectiveness. The VHI consists of 30 questions, divided into three subscales, with scores ranging from 0 to 120, where higher scores indicate a greater perceived handicap
Measured: From enrollment to the end of treatment at 5 or 8 weeks"
Secondary outcomes (1)
Consensus Auditory-Perceptual Evaluation of Voice
Perceptual Voice Quality measurement
Measured: From enrollment to the end of treatment at 5 or 8 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Sep 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphoniaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145086
- Sponsor's protocol ID
- 1R15DC021255-01A1
- Other IDs
- 1R15DC021255-01A1
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- 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 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translaryngeal Vibration for Hyperfunctional Voice Disorders
- ClinicalTrials.gov ID
- NCT07145086
- Acronym / sponsor ID
- 1R15DC021255-01A1
- Conditions
- Dysphonia, Muscle Tension Dysphonia
- Keywords
- Dysphonia, Muscle Tension Dysphonia, Voice Therapy, Vibration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 28 Aug 2025 (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.
Contemporary treatments for hyperfunctional voice disorders such as muscle tension dysphonia (MTD) are effective but typically do not restore voice handicap or voice function to normal thresholds. Recent reports of vibration as a voice therapy modality have been published, but many questions remain about the efficacy of this tool. The current project addresses these problems through a blinded and randomized controlled trial to investigate the efficacy of local translaryngeal vibration for MTD and the dose-response relationship of this modality when compared to treatment without vibration.
Detailed description
High-quality research designs have demonstrated that voice therapy has a positive impact on hyperfunctional voice disorders associated with muscle tension dysphonia (MTD). Among the options of behavioral voice therapy for MTD, one of the most effective evidence-based approaches is flow phonation (a.k.a., stretch-and-flow voice therapy). However, the phenomenon of post-treatment outcome measures remaining substantially outside the range of normal is a ubiquitous finding in studies investigating this and other voice therapy approaches. From both a cost burden and quality of life perspective, this phenomenon supports a need to develop and refine voice therapy treatment approaches to promote better outcomes. Vibration is a physical modality that has a historical use in the rehabilitation professions, but only recently has it been scientifically studied as a modality for voice therapy when used by speech-language pathologists. When applied locally on the perilaryngeal surface as a local translaryngeal vibration therapy (LTLV), early research has demonstrated beneficial effects on voice physiology and clinical outcomes. Further high-quality clinical research studies are needed to evaluate the efficacy of LTLV as a modality for voice disorders and to better understand the effects of vibration and effective vibration dose on voice rehabilitation outcomes. The research proposed in this R15 has the potential to transform clinical practice of treatment for MTD, the most common voice disorder among treatment-seeking populations. That potential is vested in the pursuit of three specific aims: (1) determine the clinical efficacy of LTLV as a concurrent treatment using flow phonation voice therapy in patients with MTD, and (2) determine the effect of treatment dose on clinical response associated with treatment outcomes. In addition to the potential impact of this R15, the innovative of approach of using LTLV as a concurrent modality with flow phonation combined with investigation of the most effective frequency parameter for clinical application represents a pioneering approach to advance the field of clinical voice practice in speech-language pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Five Week Therapy | Experimental | Behavioral: Voice therapy with vibrationParticipants receive five weeks of voice therapy with vibration |
| Eight Week Therapy | Active comparator | Behavioral: Voice therapy with vibrationParticipants receive eight weeks of voice therapy with vibration |
| Voice Therapy with Placebo | Placebo comparator | Behavioral: Voice therapy with vibrationParticipants receive eight weeks of voice therapy with vibration placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a) diagnosis by an otolaryngologist of hyperfunctional dysphonia (MTD) without benign mid-membranous lesion (i.e., primary MTD or non-phonotraumatic hyperfunction) with and a recommendation for voice therapy, ((b) confirmation of dysphonia by a comprehensive voice evaluation conducted by a speech-language pathologist with experience in the evaluation and treatment of voice disordered populations, (c) to prevent floor effects of our primary outcome variable, participants will be required to exhibit a pre-treatment VHI score of >20, as this is the upper range for normal cutoff values in studies which have demonstrated high sensitivity and specificity for this tool (Behlau et al., 2016), (d) 18 years of age or older, (e) no history of local vibration therapy as part of a rehabilitation treatment program.
Key exclusion criteria (1 listed)
- Unable to receive vibration to neck area
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 |
|---|---|---|
| Voice therapy with vibrationVoice therapy with a novel vibration device will be delivered for five or eight weeks depending on group allocation. All participants will receive flow phonation voice therapy. | Behavioural | Eight Week Therapy, Five Week Therapy, Voice Therapy with Placebo |
Primary outcome
Voice Handicap Index
Time frame: From enrollment to the end of treatment at 5 or 8 weeks"
The Voice Handicap Index (VHI) is a self-assessment tool used to evaluate how a voice disorder impacts a person's daily life, encompassing functional, physical, and emotional aspects. It helps quantify the perceived handicap caused by a voice problem, aiding in diagnosis, treatment planning, and assessing treatment effectiveness. The VHI consists of 30 questions, divided into three subscales, with scores ranging from 0 to 120, where higher scores indicate a greater perceived handicap
1 secondary outcome
Consensus Auditory-Perceptual Evaluation of Voice
Time frame: From enrollment to the end of treatment at 5 or 8 weeks"
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 28 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Voice therapy with vibration in people with Dysphonia and Muscle Tension Dysphonia, run by Texas Christian University 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 1 inclusion and 1 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 28 Aug 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Christopher R Watts, Ph.D. (817-266-7891, c.watts@tcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice Handicap Index (time frame: From enrollment to the end of treatment at 5 or 8 weeks"). 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 28 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.