Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
6 participants
INTERVENTIONAL
2025-06-05
2025-07-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Acoustic and Perceptual Effects of Intonation Training in Gender Diverse People
NCT05204732
Dysphonia, Distress, and Perceived Control: Technology Based Assessment and Intervention
NCT03576365
Visual Acoustic Biofeedback for RSE Via Telepractice
NCT04858022
Voice Feminisation in Transgender Women
NCT03899896
Testing a Smart Phone App to Enhance Voice Therapy Adherence
NCT04002336
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experiment group
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.
Visual-acoustic biofeedback: experimental
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Visual-acoustic biofeedback: experimental
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
New York University
OTHER
University of Central Florida
OTHER
University of Cincinnati
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vesna D Novak, PhD
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Cincinnati
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-0831
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.