Defining Clinically Important Differences in Cepstral and Spectral Measures in Individuals With and Without Phonotrauma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cepstral Peak Prominence
研究概览
简要总结
There is a substantial need to identify objective measures associated with hyperadduction of the vocal folds to recognize those at higher risk of developing phonotrauma so that risk mitigation strategies can be implemented before phonotrauma develops. The overall objective of this proposed project is to investigate the sensitivity and direction of change in cepstral peak prominence (CPP) and the magnitude difference between the first two harmonics of the voice spectrum (H1-H2) in response to varied phonation patterns, which will be addressed using the following two aims:
Aim 1: Determine how CPP and H1-H2 change as a function of using pressed voice production in individuals without laryngeal pathology.
Aim 2: Examine the sensitivity (minimally detectable change) and responsiveness (minimal clinically important difference) of CPP and H1-H2 to detect changes in different voice production conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Control Group:
- •Inclusion Criteria:
- •18-65 years of age (to avoid confounding physiological factors related to puberty or presbyphonia)
- •No history of or current voice disorder
- •Auditory perceptual presentation globally within functional limits (as determined by a voice specialized SLP).
排除标准
- •Atypical auditory-perceptual voice presentation
- •History of voice disorder or laryngeal surgery.
- •Patient Group:
- •Inclusion Criteria:
- •Diagnosed with phonotrauma (i.e., vocal fold nodules, vocal fold polyp, vocal fold pseudocyst, mid-fold edema) by a laryngologist.
- •18-65 years of age
- •Exclusion Criteria:
- •Diagnosis of voice disorder not related to phonotrauma (e.g., vocal fold immobility, laryngeal dystonia, primary muscle tension dysphonia, etc.)
- •Previous history of laryngeal surgery or voice therapy (to avoid confounding effects of previous treatment).
结局指标
主要结局
Cepstral Peak Prominence
时间窗: 1 year
Cepstral peak prominence is a measure of the periodic energy of the acoustic voice signal.
The difference between the first and second harmonic (H1-H2)
时间窗: 1 year
H1-H2 is a spectral measure derived from the acoustic voice signal that correlates with glottal configuration.
Average closing velocity
时间窗: 1 year
Vocal fold closing phase velocity averaged across 100 vibratory cycles
次要结局
未报告次要终点
研究者
Laura Toles, PhD
Assistant Professor
University of Texas Southwestern Medical Center