Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes

Обзор

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.

Подробное описание

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.

Studies have shown that CTT leads to meaningful improvements in voice-related quality of life both immediately and up to three months after therapy. It is now being used in national research studies and has gained recognition as a promising, evidence-based therapy. The current research will compare CTT to traditional methods over a full year, helping to answer important questions about what makes voice therapy work-and how to help more people benefit from it long-term.

Вмешательства

• Другое Hierarchical method
  Participants in the hierarchical version of Conversation Training Therapy (CTTH) will receive four weekly sessions of voice therapy. This approach gradually increases the difficulty of speaking tasks-from simple sounds to full conversations-based on the participant's progress. The therapy begins with basic awareness and speech sounds (e.g., consonant-vowel pairs), then progresses through words, phrases, and sentences, culminating in natural conversation. Each level must be completed with at leas
• Другое Non Hierarchical method
  The therapy includes four weekly sessions and several key techniques: Clear Speech: Speaking clearly, like leaving an important voicemail. Awareness Training: Paying attention to how the voice sounds and feels in the mouth and face. Negative Practice: Switching between their "bad" voice and "good" therapy voice to recognize and improve differences. Embedded Gestures: Briefly holding certain speech sounds to reduce vocal strain and boost clarity. Prosody and Projection: Working on pitch, rhy

Первичные конечные точки

• Change in Voice Handicap Index-10 (VHI-10) score [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (12)

• Auditory- Perceptual severity [Срок оценки: Baseline , 3 month, 6 month, 12 month]
• Stroboscopic changes: Glottal Closure [Срок оценки: Baseline, Post intervention (1 week), 3 month, 6 month, 12 month]
• Stroboscopic changes: Amplitude [Срок оценки: Baseline, Post intervention (1 week), 3 month, 6 month, 12 month]
• Stroboscopic changes: Mucosal Wave [Срок оценки: Baseline, Post intervention (1 week), 3 month, 6 month, 12 month]
• Stroboscopic changes: Free edge contour [Срок оценки: Baseline, Post intervention (1 week), 3 month, 6 month, 12 month]
• Stroboscopic changes: Phase closure [Срок оценки: Baseline, Post intervention (1 week), 3 month, 6 month, 12 month]
• Stroboscopic changes: Phase symmetry [Срок оценки: Baseline, Post intervention (1 week), 3 month, 6 month, 12 month]
• Stroboscopic changes: Regularity percentage [Срок оценки: Baseline, Post intervention (1 week), 3 month, 6 month, 12 month]
• Aerodynamic changes: Average airflow in speech [Срок оценки: Baseline, Post intervention (1 week), 3 month, 6 month, 12 month]
• Aerodynamic changes: Average number of breaths [Срок оценки: Baseline, Post intervention (1 week), 3 month, 6 month, 12 month]
• Aerodynamic changes: Average speaking duration [Срок оценки: Baseline, Post intervention (1 week), 3 month, 6 month, 12 month]
• Adherence [Срок оценки: Baseline, end of study (12 month)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Emory Voice Center at Emory University Hospital Midtown — Atlanta

Идентификаторы

NCT: NCT07176988 · STUDY00009121 · 1R01DC022026-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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