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临床试验/NCT07017595
NCT07017595终止不适用

Improving the Accessibility of Gender-affirming Voice Training With Visual-acoustic Biofeedback

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年6月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
1
主要终点
Intrinsic Motivation Inventory (IM)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •At least 18 years old.
  • •Native speaker of American English - must have been exposed to it by the age of
  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Visual-acoustic biofeedback: experimental (Behavioral)

结局指标

主要结局

Intrinsic Motivation Inventory (IM)

时间窗: During the first and fourth intervention sessions

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.

Time on task

时间窗: Data collected throughout the three-week duration of training

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vesna D Novak, PhD

Associate Professor

University of Cincinnati

研究点 (1)

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