Speakers With Neurogenic Voice DisordersNCT07474740
Evaluating the Efficacy of Voice Therapy for Neurogenic Voice Disorders
A study testing Breathy voice in people with Speakers With Neurogenic Voice Disorders, run by University of Texas at Austin at 1 site in United States.
Trial summary
The goal of this study is to evaluate the efficacy of voice therapy for neurogenic voice disorders. The main questions are: Does voice therapy improve patient-reported quality of life in speakers with neurogenic voice disorders? Does voice therapy improve listener perception of voice in speakers with neurogenic voice… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Speakers With Neurogenic Voice Disorders
- What is being tested?
- Breathy voice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2024to 4 Jun 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of essential tremor by a physician
- Self-reported, physician-identified, or speech-language pathologist-identified vocal tremor
- Ability to speak and read English
- Ability to follow instructions and pay attention to tasks
Who cannot join
- History of surgery on the oral cavity, larynx, pharynx, or respiratory system that currently affects speech or voice
- Current respiratory disorder unrelated to essential tremor that affects speech or voice
- Score 20 points or below on the Mini-Mental Status Examination
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: Characterization and Treatment of Essential Vocal Tremor
The goal of this study is to evaluate the efficacy of voice therapy for neurogenic voice disorders. The main questions are:
Does voice therapy improve patient-reported quality of life in speakers with neurogenic voice disorders? Does voice therapy improve listener perception of voice in speakers with neurogenic voice disorders? Does voice therapy improve acoustical analyses of voice in speakers with neurogenic voice disorders? Does voice therapy improve physiologic function in speakers with neurogenic voice disorders?
Read the detailed description
Neurogenic voice disorders negatively impact communication-related quality of life for millions of patients. Yet current options for medical treatment including pharmacological and surgical interventions do not consistently improve voice and can have adverse effects. Although some patients with neurogenic voice disorders receive behavioral treatment like voice therapy, systematic treatment research evaluating the efficacy of behavioral treatment is limited. For example, in speakers with voice disorders related to essential tremor, the most common movement disorder in the world, only five studies have evaluated the effects of behavioral interventions. Of these studies, two were case studies (N=1, N=2), two were single-case experiments (N=1, N=3), and one was a prospective group study comparing control and experimental conditions (N=10). These studies evaluated a variety of treatment ingredients using various functional, perceptual, and acoustical treatment outcomes. However, some treatment ingredients and outcome measures were not specific to the underlying voice impairments in essential tremor. In neurogenic voice disorders with other etiologies like dystonia, more studies with larger sample sizes have been conducted. However, only eight studies have been published: two were case studies (N=1, N=1), one was a single-case experiment (N=1), one was a prospective group study comparing pre- and post-treatment phases (N=36), one was a retrospective group study comparing control and experimental conditions (N=37), one was a randomized cross-over study (N=9), one was a non-randomized controlled trial (N=17), and one was a randomized controlled trial (N=31). These studies also evaluated various treatment ingredients using functional, perceptual, and acoustical outcomes, as well as aerodynamic and acoustic outcomes. But again, some treatment ingredients and outcome measures were not specific to the underlying voice impairments related to dystonia. Finally, although a considerably higher number of treatment studies with greater sample sizes have been conducted with speakers who have voice disorders related to Parkinson's disease, the most widely studied treatment ingredients have limitations. For example, Lee Silverman Voice Therapy requires high-intensity, high-frequency treatment provided by speech-language pathologists with specialized training, and expiratory muscle strength training is also high-frequency, high-intensity treatment that requires specific equipment and physiologic capabilities. Thus, there is an important need for systematic treatment research in speakers with neurogenic voice disorders using treatment ingredients and outcome measures that are specific to patients' neurophysiologic impairments and functional limitations.
- Conditions
- Speakers With Neurogenic Voice Disorders
- Being tested
- Breathy voice
- Keywords
- Essential vocal tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathy voiceBehavioural
Participants will be trained to produce a breathy voice to reduce the perceptual severity of vocal tremor
| Study group | Role | What they receive |
|---|---|---|
| Breathy voice as a compensatory strategy for vocal tremor | Experimental | Not described Receives: Behavioral: Breathy voice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported outcome measures
Participants will be asked to rate their perception of the voice strategy on a 6-point Likert scale (0 = not at all, 5 = very much): 1) My voice was shaky when I used the strategy, 2) It was effortful to speak when I used the strategy, 3) It was difficult to use the strategy, 4), I liked the sound of my voice when I used the strategy.
Measured: Participants will complete ratings during the treatment phase at the beginning of the first treatment session and at the end of the last treatment session.
Auditory-perceptual ratings
Listeners will be asked to complete perceptual ratings for the participants' voices by marking the severity of the 'shakiness' on a visual-analog scale (0 = not shaky, 100 = very shaky).
Measured: Listeners will rate samples from all study phases within two years after all data have been collected from all study participants.
Acoustical analyses - extent of modulation
The extent of fundamental frequency and intensity modulation in percent will be measured in participants' sustained vowels as an estimate of tremor magnitude.
Measured: Audio recordings from all study phases will be analyzed within 2 years after completing data collection.
Acoustical analyses - modulation rate
The rate of fundamental frequency and intensity modulation in Hertz will be measured in participants' sustained vowels as an estimate of tremor speed.
Measured: Audio recordings from all study phases will be analyzed within 2 years after completing data collection.
Acoustical analyses - cepstral peak prominence
The cepstral peak prominence will be measured in participants' sustained vowels and connected speech as an estimate of 'breathiness.'
Measured: Audio recordings from all study phases will be analyzed within 2 years after completing data collection.
Secondary outcomes (1)
Acoustical analyses - voice breaks
The number and duration of voice breaks will be measured in participants' sustained vowels.
Measured: Audio recordings from all study phases will be analyzed within 2 years after completing data collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start4 Jun 2024
- Primary completion4 Jun 2028 (estimated)
- Study completion4 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speakers With Neurogenic Voice DisordersStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosemary Lester-Smith, University of Texas at Austin
- Investigators
- Rosemary A Lester-Smith, Ph.D., Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474740
- Sponsor's protocol ID
- 2019010036
- Status last verified
- Mar 2026
- First submitted
- 15 Aug 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will involve a small sample of speakers with neurogenic voice disorders. The extracted fundamental frequency contours for participants' sustained vowel productions will be made available upon request for research purposes after the data have been published. In addition, deidentified information about participants' medical and voice histories, audio recordings, and rating scale responses will be shared with external collaborators as data are collected and in the future. De-identified coded Data will also be stored and shared through the Texas Data Repository for our modulation analysis output, rating scale, and cognitive test data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Treatment of Essential Vocal Tremor
- ClinicalTrials.gov ID
- NCT07474740
- Acronym / sponsor ID
- 2019010036
- Conditions
- Speakers With Neurogenic Voice Disorders
- Keywords
- Essential vocal tremor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 4 Jun 2028 (estimated)
- Study completion
- 4 Jun 2028 (estimated)
- First posted
- 16 Mar 2026 (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.
The goal of this study is to evaluate the efficacy of voice therapy for neurogenic voice disorders. The main questions are:
Does voice therapy improve patient-reported quality of life in speakers with neurogenic voice disorders? Does voice therapy improve listener perception of voice in speakers with neurogenic voice disorders? Does voice therapy improve acoustical analyses of voice in speakers with neurogenic voice disorders? Does voice therapy improve physiologic function in speakers with neurogenic voice disorders?
Detailed description
Neurogenic voice disorders negatively impact communication-related quality of life for millions of patients. Yet current options for medical treatment including pharmacological and surgical interventions do not consistently improve voice and can have adverse effects. Although some patients with neurogenic voice disorders receive behavioral treatment like voice therapy, systematic treatment research evaluating the efficacy of behavioral treatment is limited. For example, in speakers with voice disorders related to essential tremor, the most common movement disorder in the world, only five studies have evaluated the effects of behavioral interventions. Of these studies, two were case studies (N=1, N=2), two were single-case experiments (N=1, N=3), and one was a prospective group study comparing control and experimental conditions (N=10). These studies evaluated a variety of treatment ingredients using various functional, perceptual, and acoustical treatment outcomes. However, some treatment ingredients and outcome measures were not specific to the underlying voice impairments in essential tremor. In neurogenic voice disorders with other etiologies like dystonia, more studies with larger sample sizes have been conducted. However, only eight studies have been published: two were case studies (N=1, N=1), one was a single-case experiment (N=1), one was a prospective group study comparing pre- and post-treatment phases (N=36), one was a retrospective group study comparing control and experimental conditions (N=37), one was a randomized cross-over study (N=9), one was a non-randomized controlled trial (N=17), and one was a randomized controlled trial (N=31). These studies also evaluated various treatment ingredients using functional, perceptual, and acoustical outcomes, as well as aerodynamic and acoustic outcomes. But again, some treatment ingredients and outcome measures were not specific to the underlying voice impairments related to dystonia. Finally, although a considerably higher number of treatment studies with greater sample sizes have been conducted with speakers who have voice disorders related to Parkinson's disease, the most widely studied treatment ingredients have limitations. For example, Lee Silverman Voice Therapy requires high-intensity, high-frequency treatment provided by speech-language pathologists with specialized training, and expiratory muscle strength training is also high-frequency, high-intensity treatment that requires specific equipment and physiologic capabilities. Thus, there is an important need for systematic treatment research in speakers with neurogenic voice disorders using treatment ingredients and outcome measures that are specific to patients' neurophysiologic impairments and functional limitations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathy voice as a compensatory strategy for vocal tremor | Experimental | Behavioral: Breathy voice |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of essential tremor by a physician
- Self-reported, physician-identified, or speech-language pathologist-identified vocal tremor
- Ability to speak and read English
- Ability to follow instructions and pay attention to tasks
Key exclusion criteria (3 listed)
- History of surgery on the oral cavity, larynx, pharynx, or respiratory system that currently affects speech or voice
- Current respiratory disorder unrelated to essential tremor that affects speech or voice
- Score 20 points or below on the Mini-Mental Status Examination
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 |
|---|---|---|
| Breathy voiceParticipants will be trained to produce a breathy voice to reduce the perceptual severity of vocal tremor | Behavioural | Breathy voice as a compensatory strategy for vocal tremor |
Primary outcome
Patient-reported outcome measures
Time frame: Participants will complete ratings during the treatment phase at the beginning of the first treatment session and at the end of the last treatment session.
Participants will be asked to rate their perception of the voice strategy on a 6-point Likert scale (0 = not at all, 5 = very much): 1) My voice was shaky when I used the strategy, 2) It was effortful to speak when I used the strategy, 3) It was difficult to use the strategy, 4), I liked the sound of my voice when I used the strategy.
Auditory-perceptual ratings
Time frame: Listeners will rate samples from all study phases within two years after all data have been collected from all study participants.
Listeners will be asked to complete perceptual ratings for the participants' voices by marking the severity of the 'shakiness' on a visual-analog scale (0 = not shaky, 100 = very shaky).
Acoustical analyses - extent of modulation
Time frame: Audio recordings from all study phases will be analyzed within 2 years after completing data collection.
The extent of fundamental frequency and intensity modulation in percent will be measured in participants' sustained vowels as an estimate of tremor magnitude.
Acoustical analyses - modulation rate
Time frame: Audio recordings from all study phases will be analyzed within 2 years after completing data collection.
The rate of fundamental frequency and intensity modulation in Hertz will be measured in participants' sustained vowels as an estimate of tremor speed.
Acoustical analyses - cepstral peak prominence
Time frame: Audio recordings from all study phases will be analyzed within 2 years after completing data collection.
The cepstral peak prominence will be measured in participants' sustained vowels and connected speech as an estimate of 'breathiness.'
1 secondary outcome
Acoustical analyses - voice breaks
Time frame: Audio recordings from all study phases will be analyzed within 2 years after completing data collection.
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 16 Mar 2026.
- UT Voice Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study will involve a small sample of speakers with neurogenic voice disorders. The extracted fundamental frequency contours for participants' sustained vowel productions will be made available upon request for research purposes after the data have been published. In addition, deidentified information about participants' medical and voice histories, audio recordings, and rating scale responses will be shared with external collaborators as data are collected and in the future. De-identified coded Data will also be stored and shared through the Texas Data Repository for our modulation analysis output, rating scale, and cognitive test data.
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.
Rosemary A Lester-Smith, Ph.D. principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathy voice in people with Speakers With Neurogenic Voice Disorders, run by University of Texas at Austin 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. 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?
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?
Patient-reported outcome measures (time frame: Participants will complete ratings during the treatment phase at the beginning of the first treatment session and at the end of the last treatment session.). The study lists 5 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 16 Mar 2026.