Transitioning Voice of Transgender and Gender Diverse PeopleNCT05815810
Novel Delivery Method of Transgender Voice Modification Training Using a Mobile Application
A study testing Attuned: A mobile application and In-Person Voice Modification Therapy in people with Transitioning Voice of Transgender and Gender Diverse People, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
The investigators hypothesize that the mobile application they developed for transgender and gender diverse individuals (TGGD) will be equivalent or better than traditional speech therapy in improving voice quality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transitioning Voice of Transgender and Gender Diverse People
- What is being tested?
- Attuned: A mobile application and In-Person Voice Modification Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Dec 2031
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identify as a transgender individual
- Be 18 years or older
- Be able to read and write in English
- Have an iOS or Android Device
Who cannot join
- Identify as cisgender
- Experience hoarseness
- Experiencing any physical pain related to voice use
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Ithaca College
Ithaca, New York, 14850
David Bayne, PhD, CCC-SLP, 607-274-1765, dbayne@ithaca.edu
David Bayne, PhD, CCC-SLP
Weill Cornell Medicine
New York, New York, 10022
Anaïs Rameau, MD, 646-962-7464, anr2783@med.cornell.edu
Anaïs Rameau, MD
About this study
The investigators hypothesize that the mobile application they developed for transgender and gender diverse individuals (TGGD) will be equivalent or better than traditional speech therapy in improving voice quality. The investigators will measure both how the participants feel about their voices and how their voice actually sounds to see if the app is effective.
Read the detailed description
The ultimate objective of this study is to use Community-Based Participatory Research (CBPR) methods to develop an effective user-friendly, health literate, inclusive and accessible mobile application (app) to improve access to gender affirming voice modification training for transgender and gender diverse (TGGD) individuals. The immediate objectives are to understand the needs of TGGD individuals in voice care,and identify barriers to creating a pilot app with evidence-based educational content for VCMT and to evaluate subjective and objective voice outcomes of TGGD participants with app use compared to standard behavioral intervention with a speech pathologist.
- Being tested
- Attuned: A mobile application, In-Person Voice Modification Therapy
- Keywords
- Transgender, Voice therapy, Mobile Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attuned: A mobile applicationOther
Subjects will undergo voice and communication modification therapy via the Attuned application. This consists of an 11 week program consisting of different modules to learn how to modify voice (e.g., pitch, intonation, resonance). At the end of each module, participants will be given exercises to practice what they learned.
In-Person Voice Modification TherapyOther
Subjects will undergo standard of care in-person voice modification therapy at Ithaca College.
| Study group | Role | What they receive |
|---|---|---|
| Transgender and gender diverse (TGGD) individuals using the pilot app | Experimental | The investigators will develop Attuned, an open access voice and communication modification training (VCMT) app based on standard of care. Participants will undergo VCMT via the mobile application, Attuned. Participants will include healthy transgender and gender diverse (TGGD) individuals seeking voice modification to better reflect their identity. Receives: Other: Attuned: A mobile application |
| Transgender and gender diverse (TGGD) individuals receiving standard voice modification | Active comparator | VCMT via speech pathology will be compared to the efficacy of an app-based VCMT program. Participants will undergo VCMT in-person. Participants will include healthy transgender and gender diverse (TGGD) individuals seeking voice modification to better reflect their identity. Receives: Other: In-Person Voice Modification Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Transsexual Voice Questionnaire (TVQ) Scores
The Transsexual Voice Questionnaire (TVQ) is a 30-item questionnaire that assesses self-perception of voice in transgender individuals. Responses range from (1) rarely or never to (4) usually or always. Scores range from 30 (no perceived voice difficulty) to 120 (high perceived voice difficulty).
Measured: Baseline, Week 4, Week 11
Change in Transgender Self Evaluation Questionnaire (TSEQ) Scores
The Transgender Self Evaluation Questionnaire (TSEQ) is a 30-item questionnaire that assesses self perception in transgender and gender diverse individuals. Responses range from (1) never (4) always. Scores range from 30 (low voice satisfaction) to 120 (high voice satisfaction)
Measured: Baseline, Week 4, Week 11
Change in Fundamental Frequency
The acoustic measure fundamental frequency will be obtained by analyzing participant's voice recordings via multi-speech acoustic analyses program of Kay-Pentax
Measured: Baseline, Week 4, Week 11
Change in Formants
The acoustic measure formants will be obtained by analyzing participant's voice recordings via multi-speech acoustic analyses program of Kay-Pentax
Measured: Baseline, Week 4, Week 11
Secondary outcomes (1)
Usability of Mobile Application as measured by the Mobile Application Rating Scale (MARS)
The Mobile Application Rating Scale (MARS) is a 19-item scale that allows app users to rate the usability of a mobile application. Responses range from 1 (inadequate) to 5 (excellent). Scores range from 19-95 with a score of 19 corresponding to a poor and inadequate app and 95 of an excellent apps with great usability.
Measured: Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startOct 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitioning Voice of Transgender and Gender Diverse PeopleStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Ithaca College
- Responsible party
- Sponsor
- Investigators
- Anaïs Rameau, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815810
- Sponsor's protocol ID
- 21-12024240
- Status last verified
- Jun 2026
- First submitted
- 3 Apr 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Delivery Method of Transgender Voice Modification Training Using a Mobile Application
- ClinicalTrials.gov ID
- NCT05815810
- Acronym / sponsor ID
- 21-12024240
- Keywords
- Transgender, Voice therapy, Mobile Application
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Ithaca College
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 18 Apr 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.
The investigators hypothesize that the mobile application they developed for transgender and gender diverse individuals (TGGD) will be equivalent or better than traditional speech therapy in improving voice quality. The investigators will measure both how the participants feel about their voices and how their voice actually sounds to see if the app is effective.
Detailed description
The ultimate objective of this study is to use Community-Based Participatory Research (CBPR) methods to develop an effective user-friendly, health literate, inclusive and accessible mobile application (app) to improve access to gender affirming voice modification training for transgender and gender diverse (TGGD) individuals. The immediate objectives are to understand the needs of TGGD individuals in voice care,and identify barriers to creating a pilot app with evidence-based educational content for VCMT and to evaluate subjective and objective voice outcomes of TGGD participants with app use compared to standard behavioral intervention with a speech pathologist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgender and gender diverse (TGGD) individuals using the pilot app | Experimental | Other: Attuned: A mobile applicationThe investigators will develop Attuned, an open access voice and communication modification training (VCMT) app based on standard of care. Participants will undergo VCMT via the mobile application, Attuned. Participants will include healthy transgender and gender diverse (TGGD) individuals seeking voice modification to better reflect their identity. |
| Transgender and gender diverse (TGGD) individuals receiving standard voice modification | Active comparator | Other: In-Person Voice Modification TherapyVCMT via speech pathology will be compared to the efficacy of an app-based VCMT program. Participants will undergo VCMT in-person. Participants will include healthy transgender and gender diverse (TGGD) individuals seeking voice modification to better reflect their identity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Identify as a transgender individual
- Be 18 years or older
- Be able to read and write in English
- Have an iOS or Android Device
Key exclusion criteria (3 listed)
- Identify as cisgender
- Experience hoarseness
- Experiencing any physical pain related to voice use
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 |
|---|---|---|
| Attuned: A mobile applicationSubjects will undergo voice and communication modification therapy via the Attuned application. This consists of an 11 week program consisting of different modules to learn how to modify voice (e.g., pitch, intonation, resonance). At the end of each module, participants will be given exercises to practice what they learned. | Other | Transgender and gender diverse (TGGD) individuals using the pilot app |
| In-Person Voice Modification TherapySubjects will undergo standard of care in-person voice modification therapy at Ithaca College. | Other | Transgender and gender diverse (TGGD) individuals receiving standard voice modification |
Primary outcome
Change in Transsexual Voice Questionnaire (TVQ) Scores
Time frame: Baseline, Week 4, Week 11
The Transsexual Voice Questionnaire (TVQ) is a 30-item questionnaire that assesses self-perception of voice in transgender individuals. Responses range from (1) rarely or never to (4) usually or always. Scores range from 30 (no perceived voice difficulty) to 120 (high perceived voice difficulty).
Change in Transgender Self Evaluation Questionnaire (TSEQ) Scores
Time frame: Baseline, Week 4, Week 11
The Transgender Self Evaluation Questionnaire (TSEQ) is a 30-item questionnaire that assesses self perception in transgender and gender diverse individuals. Responses range from (1) never (4) always. Scores range from 30 (low voice satisfaction) to 120 (high voice satisfaction)
Change in Fundamental Frequency
Time frame: Baseline, Week 4, Week 11
The acoustic measure fundamental frequency will be obtained by analyzing participant's voice recordings via multi-speech acoustic analyses program of Kay-Pentax
Change in Formants
Time frame: Baseline, Week 4, Week 11
The acoustic measure formants will be obtained by analyzing participant's voice recordings via multi-speech acoustic analyses program of Kay-Pentax
1 secondary outcome
Usability of Mobile Application as measured by the Mobile Application Rating Scale (MARS)
Time frame: Week 11
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 22 Jun 2026.
- Individual participant dataSharing planned: No
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.
Anaïs Rameau, MD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attuned: A mobile application and In-Person Voice Modification Therapy in people with Transitioning Voice of Transgender and Gender Diverse People, run by Weill Medical College of Cornell University at 2 sites 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: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Anaïs Rameau, MD (646-962-7464, anr2783@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Transsexual Voice Questionnaire (TVQ) Scores (time frame: Baseline, Week 4, Week 11). The study lists 4 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 22 Jun 2026.