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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05815810
Enrollment
50
Registered
2023-04-18
Start date
2026-10-01
Completion date
2031-12-01
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transitioning Voice of Transgender and Gender Diverse People

Keywords

Transgender, Voice therapy, Mobile Application

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.

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.

Interventions

OTHERAttuned: 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.

OTHERIn-Person Voice Modification Therapy

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

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER
Ithaca College
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Transsexual Voice Questionnaire (TVQ) ScoresBaseline, Week 4, Week 11The 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).
Change in Transgender Self Evaluation Questionnaire (TSEQ) ScoresBaseline, Week 4, Week 11The 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)
Change in Fundamental FrequencyBaseline, Week 4, Week 11The acoustic measure fundamental frequency will be obtained by analyzing participant's voice recordings via multi-speech acoustic analyses program of Kay-Pentax
Change in FormantsBaseline, Week 4, Week 11The acoustic measure formants will be obtained by analyzing participant's voice recordings via multi-speech acoustic analyses program of Kay-Pentax

Secondary

MeasureTime frameDescription
Usability of Mobile Application as measured by the Mobile Application Rating Scale (MARS)Week 11The 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.

Countries

United States

Contacts

CONTACTAnaïs Rameau, MD
anr2783@med.cornell.edu646-962-7464
PRINCIPAL_INVESTIGATORAnaïs Rameau, MD

Weill Medical College of Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026