Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-30 @ 7:50 PM
Study NCT ID:
NCT07017595
Status:
TERMINATED
Last Update Posted:
2025-07-24
First Post:
2025-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gender-affirming Voice Training With Visual Feedback
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055154', 'term': 'Dysphonia'}], 'ancestors': [{'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'There will be only one group. Each participant will take part in the same protocol (4 virtual training sessions + "homework" between sessions).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Funding was terminated by NIH in 2025 with a statement that the research no longer meets agency priorities.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2025-05-24', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'System Usability Scale (SUS)', 'timeFrame': 'Immediately after training', 'description': "The System Usability Scale is a simple ten-item scale attitude Likert scale giving a global view of subjective assessments of usability. It has a range of 0-100, with higher scores indicating better usability. The scale will be used to collect participants' opinions about the voice training software."}], 'primaryOutcomes': [{'measure': 'Intrinsic Motivation Inventory (IM)', 'timeFrame': 'During the first and fourth intervention sessions', 'description': "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."}, {'measure': 'Time on task', 'timeFrame': 'Data collected throughout the three-week duration of training', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Acoustically measured change over time', 'timeFrame': 'Baseline (pre-intervention) and immediately after the last intervention session', 'description': 'Participants will be recorded producing a brief speech sample in their "best feminine voice" at the start and end of participation. Mean pitch, pitch range, and mean F2 frequency will be calculated for each sample. Change in these values from pre- to post-training will be used to assess the effects of the brief duration of training provided. This is considered a secondary outcome since the duration of the protocol (3 weeks) is significantly shorter than full gender-affirming voice training regimens and effects on this outcome may not yet be visible.'}, {'measure': 'Self-Efficacy Scale for Voice Modification in Trans Women', 'timeFrame': 'Baseline (pre-intervention) and immediately after the last intervention session', 'description': 'The SES-VMTW is patient-reported outcome measure consisting of 19 items that ask participants to rate their own ability to adjust the characteristics of their voice (e.g., "I can raise the pitch of my voice") and their ability to complete voice exercises under different conditions of practice (e.g., "I can organise a quiet place to practice my voice exercises"). We will administer the full questionnaire at pre- and post-training time points.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transgender', 'gender-affirming voice and communication training', 'voice training', 'voice-gender incongruence', 'transgender women', 'voice alteration', 'voice change'], 'conditions': ['Transgender Women', 'Voice Alteration']}, 'descriptionModule': {'briefSummary': '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:\n\n* How regularly would trans women use the prototype voice training software as "homework" between human-led voice training sessions?\n* In such a setting, how usable and motivating would the training software be?\n\nParticipants 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.', 'detailedDescription': "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.\n\nAfter 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).\n\nIn 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.\n\nBetween 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.\n\nAfter 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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'transgender women and nonbinary transfeminine participants', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 years old.\n* Native speaker of American English - must have been exposed to it by the age of 6.\n* Assigned male at birth, currently identifies as transgender.\n* Currently interested in gender-affirming voice training.\n* Has access to a computer and quiet room for performing voice training.\n* Able to pass a pure-tone hearing screening at 20dB HL.\n\nExclusion Criteria:\n\n* Current or previous diagnosed speech, language or hearing problems (besides voice-gender dysphoria).\n* Neurological disorder or disease (e.g., Parkinson's, tremor) or impacted nerve function to the larynx (e.g., paralysis/paresis of the vocal fold).\n* Respiratory disease (e.g., asthma).\n* Nasopharyngeal pathology or anatomical abnormality.\n* Previous voice feminization surgery.\n* Engaged in other gender-affirming voice training during period of study participation."}, 'identificationModule': {'nctId': 'NCT07017595', 'briefTitle': 'Gender-affirming Voice Training With Visual Feedback', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Improving the Accessibility of Gender-affirming Voice Training With Visual-acoustic Biofeedback', 'orgStudyIdInfo': {'id': '2023-0831'}, 'secondaryIdInfos': [{'id': 'R21DC021537', 'link': 'https://reporter.nih.gov/quickSearch/R21DC021537', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experiment group', 'description': '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.', 'interventionNames': ['Behavioral: Visual-acoustic biofeedback: experimental']}], 'interventions': [{'name': 'Visual-acoustic biofeedback: experimental', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Experiment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45221', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'We plan to share all anonymized data with other researchers. This is expected to include questionnaire answers and acoustic metrics extracted from data, but not, e.g., audio recordings or specific participant data that would allow the participant to be individually identified (e.g., date of birth).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}, {'name': 'New York University', 'class': 'OTHER'}, {'name': 'University of Central Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Vesna D Novak, PhD', 'investigatorAffiliation': 'University of Cincinnati'}}}}