Novel Delivery Method of Transgender Voice Therapy Using a Mobile Application

NCT ID: NCT05815810

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-31

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Transitioning Voice of Transgender and Gender Diverse People

Keywords

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Transgender Voice therapy Mobile Application

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Attuned: A mobile application

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

In-Person Voice Modification Therapy

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

In-Person Voice Modification Therapy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ithaca College

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anaïs Rameau, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Ithaca College

Ithaca, New York, United States

Site Status

Weill Cornell Medicine

New York, New York, United States

Site Status

Countries

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United States

Central Contacts

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Anaïs Rameau, MD

Role: CONTACT

Phone: 646-962-7464

Email: [email protected]

Facility Contacts

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Mary Pitti, CCC-SLP

Role: primary

Anaïs Rameau, MD

Role: primary

Other Identifiers

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21-12024240

Identifier Type: -

Identifier Source: org_study_id