Novel Delivery Method of Transgender Voice Therapy Using a Mobile Application

NCT05815810 | Not Yet Recruiting

• 1 other identifier: 21-12024240
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Transitioning Voice of Transgender and Gender Diverse People

Keywords

Transgender; Voice therapy; Mobile Application

Outcome Measures

Primary Outcomes (4)

• 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).

  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)

  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

  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

  Baseline, Week 4, Week 11

Secondary Outcomes (1)

• Usability of Mobile Application as measured by the Mobile Application Rating Scale (MARS)

  Week 11

Study Arms (2)

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.

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.

Other: In-Person Voice Modification Therapy

Interventions

Attuned: A mobile application OTHER

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.

Transgender and gender diverse (TGGD) individuals using the pilot app

In-Person Voice Modification Therapy OTHER

Subjects will undergo standard of care in-person voice modification therapy at Ithaca College.

Transgender and gender diverse (TGGD) individuals receiving standard voice modification

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender and non-binary individuals
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Ithaca College: collaborator

Study Sites (2)

Ithaca College

Ithaca, New York, 14850, United States

Location

Weill Cornell Medicine

New York, New York, 10022, United States

Location

Study Officials

• Anaïs Rameau, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anaïs Rameau, MD

CONTACT

646-962-7464; anr2783@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)