Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Voice Handicap Index-10 (VHI-10) score
研究概览
简要总结
This research study aims to evaluate the effect of treatment delivery method on voice outcomes over 12 months in people with a primary complaint of a voice problem, diagnosed with either non-phonotraumatic vocal hyperfunction, also known as primary muscle tension dysphonia (MTD) or phonotraumatic vocal hyperfunction, also known as benign vocal fold lesions (lesions).
The secondary objectives are:
- To evaluate acoustic correlates of clear speech and the relationship to vocal acoustic and patient-reported voice outcomes.
- To determine the association between overall dysphonia outcomes and adoption of clear speech.
详细描述
About 23 million Americans-roughly 1 in 13 people-suffer from voice problems at any given time. These issues can make it hard to speak clearly, lead to throat pain or fatigue, and affect daily life, work, and emotional well-being. The two most common types of voice problems are:
- Muscle tension dysphonia (MTD): when muscles in the throat are too tight during speaking.
- Benign vocal fold lesions: such as nodules or swelling on the vocal cords due to overuse or strain.
The most common treatment for these conditions is behavioral voice therapy, which involves working with a speech-language pathologist (SLP) to learn new ways to use the voice. However, over a third of patients drop out, and long-term success is uncertain. One major challenge is helping patients apply what they learn in therapy to their real-life conversations-a step often saved for the end of treatment or skipped entirely.
Traditional voice therapies often follow a strict step-by-step ("hierarchical") approach. Patients start with basic sounds or exercises and only work up to everyday speech later. But this method may not be the most effective, and many people struggle to use the new techniques outside the clinic.
To solve this problem, the research team developed a new method called Conversation Training Therapy (CTT). CTT flips the traditional approach: it begins with practicing clear, intentional speech in real conversation from the first session. This helps patients immediately apply new voice skills in real-life situations, which may lead to faster, more lasting results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-smoking
- •Diagnosis of either primary muscle tension dysphonia of the hyperadducted type or benign vocal fold lesions.
- •No neuro-laryngologic or age-related vocal fold changes (e.g., atrophy)
- •No history of voice therapy or voice surgery in the last year
- •No history of other serious chronic medical conditions that may affect voice (per patient report), Normal hearing (determined by pure tone audiometry), stimulable and appropriate for behavioral voice intervention as determined by a voice-specialized speech-language pathologist and laryngologist,
- •Willingness to attend all therapeutic interventions and follow-up sessions
- •Willingness to use a smartphone to record practice
排除标准
- •History of voice therapy or voice surgery in the last year
- •Serious chronic medical condition that may affect voice (per patient report)
- •Abnormal hearing ability (despite appropriate amplification)
- •Other laryngeal disorders not attributed to primary MTD and benign vocal fold lesions,
- •Not stimulable or inappropriate for behavioral voice intervention as determined by a voice-specialized speech-language pathologist and laryngologist
- •Unwillingness to attend therapeutic intervention and follow-up sessions
- •Unwillingness to use a smartphone to record practice
- •Pregnant women
- •Prisoners
- •Cognitive impairment or impaired decision-making capacity
研究组 & 干预措施
Non-Hierarchical Conversation Training Therapy (CTT)
干预措施: Non Hierarchical method (Other)
Hierarchical Conversation Training Therapy (CTT-H)
干预措施: Hierarchical method (Other)
结局指标
主要结局
Change in Voice Handicap Index-10 (VHI-10) score
时间窗: During intervention (4 week period of active treatment: Week 1, Week 2, Week 3, Week 4) immediately post treatment ( week 5), 3month, 6 month and 12-months post treatment
The Voice Handicap Index-10 (VHI-10) is a 10-question survey used to measure how much a voice problem affects a person's daily life. Scores range from 0 to 40, with higher scores indicating a greater perceived voice handicap. Each item is rated from 0 ("never") to 4 ("always") A higher score means greater voice-related disability as perceived by the patient.
Change in vowel space
时间窗: During intervention (4 week period of active treatment: Week 1, Week 2, Week 3, Week 4) immediately post treatment ( week 5), 3month, 6 month and 12-months post treatment.
Change in vowel space refers to alterations in the acoustic range of vowel production-specifically, how far apart vowels are from each other in the formant frequency space (typically plotted as F1 vs F2, the first and second formants). It reflects the clarity, precision, and distinctiveness of vowel articulation during speech. Vowel space will be measured through acoustic analysis of participants' spoken sentences from the Sentence Intelligibility Test (SIT). These sentences include both corner vowels (e.g., heed, had, hod, who'd) and non-corner vowels (e.g., hid, head, hut, hood), allowing for detailed tracking of articulatory patterns
次要结局
- Auditory- Perceptual severity(Baseline , 3 month, 6 month, 12 month)
- Stroboscopic changes: Phase closure(Baseline, Post intervention (1 week), 3 month, 6 month, 12 month)
- Stroboscopic changes: Phase symmetry(Baseline, Post intervention (1 week), 3 month, 6 month, 12 month)
- Stroboscopic changes: Regularity percentage(Baseline, Post intervention (1 week), 3 month, 6 month, 12 month)
- Aerodynamic changes: Average airflow in speech(Baseline, Post intervention (1 week), 3 month, 6 month, 12 month)
- Aerodynamic changes: Average number of breaths(Baseline, Post intervention (1 week), 3 month, 6 month, 12 month)
- Aerodynamic changes: Average speaking duration(Baseline, Post intervention (1 week), 3 month, 6 month, 12 month)
- Adherence(Baseline, end of study (12 month))
- Practice fidelity(Baseline, end of study (12 month))
- Stroboscopic changes: Glottal Closure(Baseline, Post intervention (1 week), 3 month, 6 month, 12 month)
- Stroboscopic changes: Amplitude(Baseline, Post intervention (1 week), 3 month, 6 month, 12 month)
- Stroboscopic changes: Mucosal Wave(Baseline, Post intervention (1 week), 3 month, 6 month, 12 month)
- Stroboscopic changes: Free edge contour(Baseline, Post intervention (1 week), 3 month, 6 month, 12 month)
研究者
Amanda Gillespie
Associate Professor
Emory University