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NCT Number: NCT05815810

Novel Delivery Method of Transgender Voice Modification Training 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ithaca College, Ithaca, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

In-Person Voice Modification Therapy

Other

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

Primary outcomes

  1. 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).

  2. 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)

  3. 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

  4. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anaïs Rameau, MD

CONTACT

[email protected]

646-962-7464

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Ithaca College

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Apr 18, 2023
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.