Novel Delivery Method of Transgender Voice Modification Training Using a Mobile Application

June 17, 2026 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Ithaca, New York, United States, 14850
        • Ithaca College
        • Contact:
        • Principal Investigator:
          • David Bayne, PhD, CCC-SLP
      • New York, New York, United States, 10022
        • Weill Cornell Medicine
        • Contact:
        • Principal Investigator:
          • Anaïs Rameau, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Identify as a transgender individual
  • Be 18 years or older
  • Be able to read and write in English
  • Have an iOS or Android Device

Exclusion Criteria:

  • Identify as cisgender
  • Experience hoarseness
  • Experiencing any physical pain related to voice use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transgender and gender diverse (TGGD) individuals using the pilot app
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.
Other: Attuned: A mobile application
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.
Active Comparator: Transgender and gender diverse (TGGD) individuals receiving standard voice modification
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.
Other: In-Person Voice Modification Therapy
Subjects will undergo standard of care in-person voice modification therapy at Ithaca College.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline, Week 4, Week 11
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)
Baseline, Week 4, Week 11
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
Baseline, Week 4, Week 11
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
Baseline, Week 4, Week 11

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Usability of Mobile Application as measured by the Mobile Application Rating Scale (MARS)
Time Frame: Week 11
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.
Week 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ithaca College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anaïs Rameau, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-12024240

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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