Clinical trial NCT07017595: Gender-affirming Voice Training With Visual Feedback
Official title: Improving the Accessibility of Gender-affirming Voice Training With Visual-acoustic Biofeedback
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transgender Women
Voice Alteration
Keywords: transgender
gender-affirming voice and communication training
voice training
voice-gender incongruence
transgender women
voice alteration
voice change
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: New York University
name: University of Central Florida
First posted: 2025-06-12
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There will be only one group. Each participant will take part in the same protocol (4 virtual training sessions + "homework" between sessions).
Primary purpose: TREATMENT

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.

Detailed description: In an initial virtual assessment session (conducted via a password-protected Zoom room), a researcher will explain the protocol, obtain informed consent, collect participant demographics and other self-report data, and obtain baseline recordings of the participant's voice while speaking different utterances.

After the initial assessment session, each participant will take part in four virtual training sessions (on day 1, after approximately 1 week, after approximately 2 weeks, after approximately 3 weeks) provided on an individual basis by a certified speech-language pathologist (SLP).

In the first session (1 hour), the SLP will assess each participant's baseline ability to modify their pitch and resonance and will introduce the voice training software. They will provide strategies that participants may use to manipulate their pitch or resonance (e.g., for resonance, changing the positioning of the tongue in their mouth or changing the shape of the lips). For the remainder of the session, the SLP will guide the participant through exercises deemed appropriate to the participant's ability, both with and without the software. At the end of the session, the SLP will prescribe pitch and/or resonance exercises to be performed at home with the voice training software, with a suggested duration of 2x 15 minutes each day. Additional one-hour virtual training sessions with the SLP will be held at the end of weeks 1, 2, and 3.

Between sessions, participants will be asked to exercise on their own and report the duration and type of practice using a self-report log, though there will be no mechanism to enforce the unsupervised exercise.

After the last training session, participants will take part in a final assessment session where the same recordings as in the initial assessment session will be obtained again and additional self-report data will be collected.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Intrinsic Motivation Inventory (IM)
timeFrame: During the first and fourth intervention sessions
measure: Time on task
timeFrame: Data collected throughout the three-week duration of training
Secondary outcomes:
measure: Acoustically measured change over time
timeFrame: Baseline (pre-intervention) and immediately after the last intervention session
measure: Self-Efficacy Scale for Voice Modification in Trans Women
timeFrame: Baseline (pre-intervention) and immediately after the last intervention session
Other outcomes:
measure: System Usability Scale (SUS)
timeFrame: Immediately after training
Locations:
Study officials:
References: