Transgender WomenNCT07017595
Gender-affirming Voice Training With Visual Feedback
A study testing Visual-acoustic biofeedback: experimental in people with Transgender Women and Voice Alteration, run by University of Cincinnati at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if prototype software can be used to train vocal pitch and resonance in trans women. The main questions it aims to answer are: How regularly would trans women use the prototype voice training software as "homework" between human-led voice training sessions? In such a… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Transgender Women, Voice Alteration
- What is being tested?
- Visual-acoustic biofeedback: experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2025to 18 Jul 2025
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Native speaker of American English - must have been exposed to it by the age of 6.
- Assigned male at birth, currently identifies as transgender.
- Currently interested in gender-affirming voice training.
- Has access to a computer and quiet room for performing voice training.
- Able to pass a pure-tone hearing screening at 20dB HL.
Who cannot join
- Current or previous diagnosed speech, language or hearing problems (besides voice-gender dysphoria).
- Neurological disorder or disease (e.g., Parkinson's, tremor) or impacted nerve function to the larynx (e.g., paralysis/paresis of the vocal fold).
- Respiratory disease (e.g., asthma).
- Nasopharyngeal pathology or anatomical abnormality.
- Previous voice feminization surgery.
- Engaged in other gender-affirming voice training during period of study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Accessibility of Gender-affirming Voice Training With Visual-acoustic Biofeedback
The goal of this clinical trial is to learn if prototype software can be used to train vocal pitch and resonance in trans women. The main questions it aims to answer are:
- How regularly would trans women use the prototype voice training software as "homework" between human-led voice training sessions?
- In such a setting, how usable and motivating would the training software be?
Participants will first have their voice measured, then take part in four virtual sessions (one per week) led by a speech-language pathologist. In each session, the clinician will guide the participant through several voice exercises both with and without the software. Participants will be asked to use the software to exercise on their own for about 2x 15 minutes a day between virtual sessions.
Read the detailed description
In an initial virtual assessment session (conducted via a password-protected Zoom room), a researcher will explain the protocol, obtain informed consent, collect participant demographics and other self-report data, and obtain baseline recordings of the participant's voice while speaking different utterances.
After the initial assessment session, each participant will take part in four virtual training sessions (on day 1, after approximately 1 week, after approximately 2 weeks, after approximately 3 weeks) provided on an individual basis by a certified speech-language pathologist (SLP).
In the first session (1 hour), the SLP will assess each participant's baseline ability to modify their pitch and resonance and will introduce the voice training software. They will provide strategies that participants may use to manipulate their pitch or resonance (e.g., for resonance, changing the positioning of the tongue in their mouth or changing the shape of the lips). For the remainder of the session, the SLP will guide the participant through exercises deemed appropriate to the participant's ability, both with and without the software. At the end of the session, the SLP will prescribe pitch and/or resonance exercises to be performed at home with the voice training software, with a suggested duration of 2x 15 minutes each day. Additional one-hour virtual training sessions with the SLP will be held at the end of weeks 1, 2, and 3.
Between sessions, participants will be asked to exercise on their own and report the duration and type of practice using a self-report log, though there will be no mechanism to enforce the unsupervised exercise.
After the last training session, participants will take part in a final assessment session where the same recordings as in the initial assessment session will be obtained again and additional self-report data will be collected.
- Conditions
- Transgender Women, Voice Alteration
- Being tested
- Visual-acoustic biofeedback: experimental
- Keywords
- transgender, gender-affirming voice and communication training, voice training, voice-gender incongruence, transgender women, voice alteration, voice change
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual-acoustic biofeedback: experimentalBehavioural
Visual-acoustic biofeedback treatment incorporates elements of traditional voice training, including auditory models, verbal descriptions of articulator placement, and cues for repetitive motor practice using images and diagrams of the vocal tract as visual aids. Our experimental software will provide several options for visualizing the fundamental frequency of the voice (for targets involving vocal pitch) and for visualizing vocal tract resonances. Custom targets for pitch and resonance will be created for each participant based on their baseline voice characteristics and personal voice goals. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments influence the proximity of their output to the target.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | This group will be given access to our prototype software for pitch and resonance training. They will go through 4 virtual sessions of expert-guided voice training, with the software used as part of the sessions, and will use the software on their own between sessions. Receives: Behavioral: Visual-acoustic biofeedback: experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrinsic Motivation Inventory (IM)
The IMI is a patient-reported outcome measure that collects information about participants' experience of interacting with a particular task or technology. The total instrument consists of 45 items under seven subcategories (Interest/Enjoyment, Perceived Competence, Effort/Importance, Pressure/Tension, Perceived Choice, Value/Usefulness, and Relatedness). We will use an 8-item version of the scale that has been adopted in previous lab-based studies on motivation, including several by our group. The IMI will be administered after participants are first exposed to their assigned software in the first training session, and again at the end of the three-week training period.
Measured: During the first and fourth intervention sessions
Time on task
Participants will be provided with a standard log to record their minutes of practice over the three-week training period. The total number of self-reported minutes of practice completed will serve as a primary outcome measure of interest and will be compared to the a priori requested 30 minutes per day.
Measured: Data collected throughout the three-week duration of training
Secondary outcomes (2)
Acoustically measured change over time
Participants will be recorded producing a brief speech sample in their "best feminine voice" at the start and end of participation. Mean pitch, pitch range, and mean F2 frequency will be calculated for each sample. Change in these values from pre- to post-training will be used to assess the effects of the brief duration of training provided. This is considered a secondary outcome since the duration of the protocol (3 weeks) is significantly shorter than full gender-affirming voice training regimens and effects on this outcome may not yet be visible.
Measured: Baseline (pre-intervention) and immediately after the last intervention session
Self-Efficacy Scale for Voice Modification in Trans Women
The SES-VMTW is patient-reported outcome measure consisting of 19 items that ask participants to rate their own ability to adjust the characteristics of their voice (e.g., "I can raise the pitch of my voice") and their ability to complete voice exercises under different conditions of practice (e.g., "I can organise a quiet place to practice my voice exercises"). We will administer the full questionnaire at pre- and post-training time points.
Measured: Baseline (pre-intervention) and immediately after the last intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start5 Jun 2025
- Primary completion11 Jul 2025
- Study completion18 Jul 2025
Why it stopped: Funding was terminated by NIH in 2025 with a statement that the research no longer meets agency priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transgender WomenStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There will be only one group. Each participant will take part in the same protocol (4 virtual training sessions + "homework" between sessions).
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), New York University, University of Central Florida
- Responsible party
- Principal investigator, Vesna D Novak, PhD, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017595
- Sponsor's protocol ID
- 2023-0831
- Other IDs
- R21DC021537
- Status last verified
- Jul 2025
- First submitted
- 24 May 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share all anonymized data with other researchers. This is expected to include questionnaire answers and acoustic metrics extracted from data, but not, e.g., audio recordings or specific participant data that would allow the participant to be individually identified (e.g., date of birth).
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Accessibility of Gender-affirming Voice Training With Visual-acoustic Biofeedback
- ClinicalTrials.gov ID
- NCT07017595
- Acronym / sponsor ID
- 2023-0831
- Conditions
- Transgender Women, Voice Alteration
- Keywords
- transgender, gender-affirming voice and communication training, voice training, voice-gender incongruence, transgender women, voice alteration, voice change
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was terminated by NIH in 2025 with a statement that the research no longer meets agency priorities.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), New York University, University of Central Florida
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 12 Jun 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.
The goal of this clinical trial is to learn if prototype software can be used to train vocal pitch and resonance in trans women. The main questions it aims to answer are:
- How regularly would trans women use the prototype voice training software as "homework" between human-led voice training sessions?
- In such a setting, how usable and motivating would the training software be?
Participants will first have their voice measured, then take part in four virtual sessions (one per week) led by a speech-language pathologist. In each session, the clinician will guide the participant through several voice exercises both with and without the software. Participants will be asked to use the software to exercise on their own for about 2x 15 minutes a day between virtual sessions.
Detailed description
In an initial virtual assessment session (conducted via a password-protected Zoom room), a researcher will explain the protocol, obtain informed consent, collect participant demographics and other self-report data, and obtain baseline recordings of the participant's voice while speaking different utterances.
After the initial assessment session, each participant will take part in four virtual training sessions (on day 1, after approximately 1 week, after approximately 2 weeks, after approximately 3 weeks) provided on an individual basis by a certified speech-language pathologist (SLP).
In the first session (1 hour), the SLP will assess each participant's baseline ability to modify their pitch and resonance and will introduce the voice training software. They will provide strategies that participants may use to manipulate their pitch or resonance (e.g., for resonance, changing the positioning of the tongue in their mouth or changing the shape of the lips). For the remainder of the session, the SLP will guide the participant through exercises deemed appropriate to the participant's ability, both with and without the software. At the end of the session, the SLP will prescribe pitch and/or resonance exercises to be performed at home with the voice training software, with a suggested duration of 2x 15 minutes each day. Additional one-hour virtual training sessions with the SLP will be held at the end of weeks 1, 2, and 3.
Between sessions, participants will be asked to exercise on their own and report the duration and type of practice using a self-report log, though there will be no mechanism to enforce the unsupervised exercise.
After the last training session, participants will take part in a final assessment session where the same recordings as in the initial assessment session will be obtained again and additional self-report data will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There will be only one group. Each participant will take part in the same protocol (4 virtual training sessions + "homework" between sessions).
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Behavioral: Visual-acoustic biofeedback: experimentalThis group will be given access to our prototype software for pitch and resonance training. They will go through 4 virtual sessions of expert-guided voice training, with the software used as part of the sessions, and will use the software on their own between sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years old.
- Native speaker of American English - must have been exposed to it by the age of 6.
- Assigned male at birth, currently identifies as transgender.
- Currently interested in gender-affirming voice training.
- Has access to a computer and quiet room for performing voice training.
Key exclusion criteria (6 listed)
- Current or previous diagnosed speech, language or hearing problems (besides voice-gender dysphoria).
- Neurological disorder or disease (e.g., Parkinson's, tremor) or impacted nerve function to the larynx (e.g., paralysis/paresis of the vocal fold).
- Respiratory disease (e.g., asthma).
- Nasopharyngeal pathology or anatomical abnormality.
- Previous voice feminization surgery.
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 |
|---|---|---|
| Visual-acoustic biofeedback: experimentalVisual-acoustic biofeedback treatment incorporates elements of traditional voice training, including auditory models, verbal descriptions of articulator placement, and cues for repetitive motor practice using images and diagrams of the vocal tract as visual aids. Our experimental software will provide several options for visualizing the fundamental frequency of the voice (for targets involving vocal pitch) and for visualizing vocal tract resonances. Custom targets for pitch and resonance will be created for each participant based on their baseline voice characteristics and personal voice goals. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments influence the proximity of their output to the target. | Behavioural | Experiment group |
Primary outcome
Intrinsic Motivation Inventory (IM)
Time frame: During the first and fourth intervention sessions
The IMI is a patient-reported outcome measure that collects information about participants' experience of interacting with a particular task or technology. The total instrument consists of 45 items under seven subcategories (Interest/Enjoyment, Perceived Competence, Effort/Importance, Pressure/Tension, Perceived Choice, Value/Usefulness, and Relatedness). We will use an 8-item version of the scale that has been adopted in previous lab-based studies on motivation, including several by our group. The IMI will be administered after participants are first exposed to their assigned software in the first training session, and again at the end of the three-week training period.
Time on task
Time frame: Data collected throughout the three-week duration of training
Participants will be provided with a standard log to record their minutes of practice over the three-week training period. The total number of self-reported minutes of practice completed will serve as a primary outcome measure of interest and will be compared to the a priori requested 30 minutes per day.
2 secondary outcomes
Acoustically measured change over time
Time frame: Baseline (pre-intervention) and immediately after the last intervention session
Self-Efficacy Scale for Voice Modification in Trans Women
Time frame: Baseline (pre-intervention) and immediately after the last intervention session
Results and safety
The study was stopped early (reason given: Funding was terminated by NIH in 2025 with a statement that the research no longer meets agency priorities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Yes. We plan to share all anonymized data with other researchers. This is expected to include questionnaire answers and acoustic metrics extracted from data, but not, e.g., audio recordings or specific participant data that would allow the participant to be individually identified (e.g., date of birth).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual-acoustic biofeedback: experimental in people with Transgender Women and Voice Alteration, run by University of Cincinnati 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 24 Jul 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?
The study was stopped early (reason given: Funding was terminated by NIH in 2025 with a statement that the research no longer meets agency priorities.). Results are not available in the source record.
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?
Intrinsic Motivation Inventory (IM) (time frame: During the first and fourth intervention sessions). 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 24 Jul 2025.