Gender-affirming Voice Training With Visual Feedback

NCT07017595 | Terminated

• 2 other identifiers: 2023-0831R21DC021537
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if prototype software can be used to train vocal pitch and resonance in trans women. The main questions it aims to answer are:

• How regularly would trans women use the prototype voice training software as "homework" between human-led voice training sessions?
• In such a setting, how usable and motivating would the training software be? Participants will first have their voice measured, then take part in four virtual sessions (one per week) led by a speech-language pathologist. In each session, the clinician will guide the participant through several voice exercises both with and without the software. Participants will be asked to use the software to exercise on their own for about 2x 15 minutes a day between virtual sessions.

Conditions

Transgender Women; Voice Alteration

Keywords

transgender; gender-affirming voice and communication training; voice training; voice-gender incongruence; transgender women; voice alteration; voice change

Outcome Measures

Primary Outcomes (2)

• Intrinsic Motivation Inventory (IM)

  The IMI is a patient-reported outcome measure that collects information about participants' experience of interacting with a particular task or technology. The total instrument consists of 45 items under seven subcategories (Interest/Enjoyment, Perceived Competence, Effort/Importance, Pressure/Tension, Perceived Choice, Value/Usefulness, and Relatedness). We will use an 8-item version of the scale that has been adopted in previous lab-based studies on motivation, including several by our group. The IMI will be administered after participants are first exposed to their assigned software in the first training session, and again at the end of the three-week training period.

  During the first and fourth intervention sessions

• Time on task

  Participants will be provided with a standard log to record their minutes of practice over the three-week training period. The total number of self-reported minutes of practice completed will serve as a primary outcome measure of interest and will be compared to the a priori requested 30 minutes per day.

  Data collected throughout the three-week duration of training

Secondary Outcomes (2)

• Acoustically measured change over time

  Baseline (pre-intervention) and immediately after the last intervention session

• Self-Efficacy Scale for Voice Modification in Trans Women

  Baseline (pre-intervention) and immediately after the last intervention session

Other Outcomes (1)

• System Usability Scale (SUS)

  Immediately after training

Study Arms (1)

Experiment group

EXPERIMENTAL

This group will be given access to our prototype software for pitch and resonance training. They will go through 4 virtual sessions of expert-guided voice training, with the software used as part of the sessions, and will use the software on their own between sessions.

Behavioral: Visual-acoustic biofeedback: experimental

Interventions

Visual-acoustic biofeedback: experimental BEHAVIORAL

Visual-acoustic biofeedback treatment incorporates elements of traditional voice training, including auditory models, verbal descriptions of articulator placement, and cues for repetitive motor practice using images and diagrams of the vocal tract as visual aids. Our experimental software will provide several options for visualizing the fundamental frequency of the voice (for targets involving vocal pitch) and for visualizing vocal tract resonances. Custom targets for pitch and resonance will be created for each participant based on their baseline voice characteristics and personal voice goals. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments influence the proximity of their output to the target.

Experiment group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: transgender women and nonbinary transfeminine participants
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old.
• Native speaker of American English - must have been exposed to it by the age of 6.
• Assigned male at birth, currently identifies as transgender.
• Currently interested in gender-affirming voice training.
• Has access to a computer and quiet room for performing voice training.
• Able to pass a pure-tone hearing screening at 20dB HL.

You may not qualify if:

• Current or previous diagnosed speech, language or hearing problems (besides voice-gender dysphoria).
• Neurological disorder or disease (e.g., Parkinson's, tremor) or impacted nerve function to the larynx (e.g., paralysis/paresis of the vocal fold).
• Respiratory disease (e.g., asthma).
• Nasopharyngeal pathology or anatomical abnormality.
• Previous voice feminization surgery.
• Engaged in other gender-affirming voice training during period of study participation.

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• New York University: collaborator
• University of Central Florida: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: There will be only one group. Each participant will take part in the same protocol (4 virtual training sessions + "homework" between sessions).

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 12, 2025
• Study Start: June 5, 2025
• Primary Completion: July 11, 2025
• Study Completion: July 18, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)