Influence of Virtual Reality on Voice Perception and Production
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Sound pressure level
研究概览
简要总结
The specific aim of the clinical trial portion of the larger research project is to obtain preliminary data on the utility of voice training (resonant voice) in the VR environment compared to a traditional clinical environment, using a mixed model within- and between-subjects randomized experimental design.
Independent Variables are (1) training and test condition (clinic room vs VR classroom for training); (2) visual speaker-to-listener distance (2m, 4m, and 6m for training); and (3) time point (baseline at 2 m, retention test at 4 m, and 9 m for transfer test). Dependent Variables are (a) vocal sound pressure level (SPL); and (b) spectral moments (spectral mean and standard deviation (in Hz and cents), skewness, and kurtosis).
The hypothesis is that a two-way interaction will be shown between training condition and time point showing greater acquisition and transfer of voice skills following training in the VR environment than in the typical clinical environment.
This series will utilize a high degree of innovation and sophisticated VR technology to identify parameters important for subsequent VR development in voice therapy, and to lay the empirical foundation for subsequent studies that build on the present work expanding both its basic science and translational value.
详细描述
This project addresses three Specific Aims. Specific Aims 1 and 2 set up many of the parameters for the clinical trial, which is addressed in Specific Aim 3. Details for the project as a whole, including the clinical trial, are as follows, copied and pasted from the grant proposal.
3.0 RESEARCH APPROACH The overall purpose is to investigate the effects of auditory, visual, and audiovisual information on the perception and production of one's own voice, using VR as an investigation tool, and to provide preliminary data on the potential utility of VR in the voice training environment. Details regarding Specific Aims are provided in the relevant page.
3.1 Participants: For SA1 and SA2, 60 vocally healthy classroom teachers will be recruited between ages 24 and 50 years, (see 3.2). At the lower end, this age range represents the earliest age at which teachers might initiate their professional teaching careers, and at the upper end, represents the average age of onset of menopause for women, and we wish to limit hormonal and other age-related influences in the data. All participants will participate in SA1 and SA2, which use the same simultaneous data collection procedures with different analyses for perceptual measures (SA1) and production measures (SA2). For SA3, which is exploratory, 10 additional healthy teachers will be recruited with the same characteristics. For all SA, inclusion and exclusion criteria are: Inclusion: By self report: (1) K-12 classroom teacher with at least two years teaching experience (SA1 and SA2) or elementary school classroom teacher (SA3), between 24 and 50 yr; (2) No history of voice disorder lasting more than two weeks, and Voice Handicap Index -10 (VHI-10)63 score < 10; (3) Lifetime non-smoker; (4) No hearing or uncorrected visual impairment; By written documentation: (5) Proof of full COVID-19 vaccination; By clinical evaluation: (6) Normal voice on days of participation, as assessed by a voice-specialized licensed SLP based on an overall severity score from the Consensus-Auditory Perceptual Evaluation of Voice (CAPE-V) < 10.65 Exclusion: By self report:(7) History of vocal fold pathology or other pathology affecting voice; (8) any acute condition that may affect voice production such as coughing, nasal congestion, or temperature greater than 98.6o F (37.0o C). Note that only vocally healthy teachers are assessed at this stage, before introducing the complexities associated with voice disorders. Those complexities will be addressed in later translational work that builds on the present series. It should be noted that the research program is ultimately relevant for teachers with voice problems, but also for the working environment of currently healthy teachers as well.
3.2 Power analyses: Power analyses assumed a medium effect size of d = 0.4, two-sided, for tests of all dependent variables across SA1 and SA2. Results suggested that an N=51 will be sufficient to detect findings for all variables with a significance level of α = 0.05 and power of 0.8. Accounting for possible attrition, 60 participants will be recruited for Aims 1 and 2. This number has been shown by our Co-Investigator Bottalico and in our own more recent preliminary data to be ample to detect significant effects similar to those investigated in the present series (e.g., differences in perceptual ratings of vocal effort and comfort, and also SPL and mean f0; (Bottalico, 2017; Bottalico et al., 2016; Daşdöğen et al., unpublished data). For SA3, which is exploratory, a total of 10 participants will be recruited to obtain preliminary data for a later clinical series.
3.3 Procedures 3.3.1 SA1 and SA2: Sixty K-12 classroom teachers will be recruited through flyers posted in the community and on social media, and through direct contact with Delaware, New Jersey, Pennsylvania, and Maryland public schools, all of which may be in close proximity to the study site at the University of Delaware. Individuals who contact the PI with an interest in participating will receive an overview of the study by telephone or secure remote connection, and if they agree, will provide informed consent. Following consent, participants will be guided to an online screening REDCap questionnaire using a HIPAA-compliant server to address all inclusion and exclusion criteria except for the clinical auditory-perceptual evaluation of voice (CAPE-V). Qualified participants will be scheduled for an in-lab appointment at the University of Delaware STAR campus voice lab. At the beginning of the appointment, the clinician will assess the participant's voice to confirm normal voice quality using the CAPE-V. Participants who pass this final screening step (overall CAPE-V severity score < 10) will proceed to experimental procedures. Others will be excused.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Masking does not apply.
入排标准
- 年龄范围
- 24 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •By self report: (1) K-12 classroom teacher with at least two years teaching experience (SA1 and SA2) or elementary school classroom teacher (SA3), between 24 and 50 yr; (2) No history of voice disorder lasting more than two weeks, and Voice Handicap Index -10 (VHI-10)63 score < 10; (3) Lifetime non-smoker; (4) No hearing or uncorrected visual impairment; By written documentation: (5) Proof of full COVID-19 vaccination; By clinical evaluation: (6) Normal voice on days of participation, as assessed by a voice-specialized licensed SLP based on an overall severity score from the Consensus-Auditory Perceptual Evaluation of Voice (CAPE-V) < 10.65.
排除标准
- •By self report:(7) History of vocal fold pathology or other pathology affecting voice; (8) any acute condition that may affect voice production such as coughing, nasal congestion, or temperature greater than 98.6o F (37.0o C). Note that only vocally healthy teachers are assessed at this stage, before introducing the complexities associated with voice disorders. Those complexities will be addressed in later translational work that builds on the present series. It should be noted that the research program is ultimately relevant for teachers with voice problems, but also for the working environment of currently healthy teachers as well.
结局指标
主要结局
Sound pressure level
时间窗: 2 weeks
Sound pressure level
Self-reported loudness
时间窗: 2 weeks
Self-reported loudness
次要结局
- Spectral moments(2 weeks)
- Self-reported vocal effort and comfort(2 weeks)
研究者
Katherine Verdolini
Professor, Communication Sciences and Disorders, Linguistics and Cognitive Science
University of Delaware
