Novel Delivery Method of Transgender Voice Therapy Using a Mobile Application

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: Not yet recruiting
• Conditions: Transitioning Voice of Transgender and Gender Diverse People
• Intervention / Treatment: Other: Attuned: A mobile application; Other: In-Person Voice Modification Therapy

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: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anaïs Rameau, MD; Phone Number: 646-962-7464; Email: anr2783@med.cornell.edu

Study Locations

• United States
  • New York
    • Ithaca, New York, United States, 14850
      • Ithaca College
      • Contact: Mary Pitti, CCC-SLP; Phone Number: 607-274-1765; Email: mpitti@ithaca.edu
      • Principal Investigator: Mary Pitti, CCC-SLP
    • New York, New York, United States, 10022
      • Weill Cornell Medicine
      • Contact: Anaïs Rameau, MD; Phone Number: 646-962-7464; Email: anr2783@med.cornell.edu
      • Principal Investigator: Anais Rameau, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 11

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Ithaca College
• Investigators: Principal Investigator: Anaïs Rameau, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Mobile Application; Transgender; Voice therapy
• Other Study ID 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