רדאר קליני AI
הניסוי הקליני NCT07176988 עבור דיספוניה, Primary Muscle Tension Dysphonia (MTD) הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
חזרה לחיפוש

Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes 120

מגייס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07176988 הוא מחקר מסוג התערבותי עבור דיספוניה, Primary Muscle Tension Dysphonia (MTD), שנמצא כעת במצב מגייס. המחקר התחיל ב-3 בספטמבר 2025 ומתוכנן לכלול 120 משתתפים. המחקר מנוהל על ידי אוניברסיטת אמורי וצפוי להסתיים ב-1 באפריל 2029. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-20 באוקטובר 2025.
סיכום קצר

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 acou...
הצג עוד
תיאור מפורט

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...
הצג עוד
כותרת רשמית

Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes

מצבים רפואיים
דיספוניהPrimary Muscle Tension Dysphonia (MTD)
מזהי מחקר נוספים
מספר NCT
NCT07176988
תחילת המחקר (בפועל)
2025-09-03
עדכון אחרון שפורסם
2025-10-20
סיום המחקר (מוערך)
2029-04
משתתפים (מתוכנן)
120
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
מגייס
מילות מפתח
Conversation Training Therapy
Hierarchical Conversation Training Therapy
primary muscle tension dysphonia
benign vocal fold lesions
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיNon-Hierarchical Conversation Training Therapy (CTT)
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 reduc...הצג עוד
ניסיHierarchical Conversation Training Therapy (CTT-H)
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...הצג עוד
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
Change in Voice Handicap Index-10 (VHI-10) score
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.
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
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
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.
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
Auditory- Perceptual severity
It is measured using the CAPE-V (Consensus Auditory-Perceptual Evaluation of Voice) scale, a standardized tool. Raters (blinded speech-language pathologists) will score overall voice severity on a 0-100 mm visual analog scale-with 0 indicating no perceived disorder and 100 indicating extremely severe voice abnormality. This rating captures a listener's perception of qualities like roughness, breathiness, strain, and overall voice quality.
Baseline , 3 month, 6 month, 12 month
Stroboscopic changes: Glottal Closure
Visual inspection during phonation. Described as: complete, anterior gap, posterior gap, hourglass, spindle, irregular, incomplete. Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month
Stroboscopic changes: Amplitude
Observed lateral movement of vocal folds. Subjectively rated as reduced, normal, or excessive. Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month
Stroboscopic changes: Mucosal Wave
Magnitude of mucosal membrane during vibration. Scored on a 0-10 scale based on visibility and extent Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month
Stroboscopic changes: Free edge contour
Shape of vocal fold edges during vibration. Rated as: normal, convex, concave, irregular, or rough Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month
Stroboscopic changes: Phase closure
Duration of open vs. closed phase during each vibratory cycle. Rated as: open phase dominates, equal, closed phase dominates Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month
Stroboscopic changes: Phase symmetry
Synchrony of left and right vocal fold movement. Rated as: symmetric or asymmetric Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month
Stroboscopic changes: Regularity percentage
Consistency of vibratory cycles over time. Expressed as % of time vibration is regular Assessments will be made using a standardized tool called VALI (Voice-Vibratory Assessment with Laryngeal Imaging), which scores multiple vibratory features.
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month
Aerodynamic changes: Average airflow in speech
Average airflow in speech - measures how much air passes through the vocal folds per second during phonation (typically in liters/second or mL/second). Abnormal airflow can indicate vocal fold dysfunction, such as incomplete closure or excessive strain. This data will be collected using the Phonatory Aerodynamic System 6600 (PAS) by PENTAX, a specialized tool for assessing voice aerodynamics. The PAS system uses a mask and microphone setup to capture airflow and sound pressure during structured speech tasks.
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month
Aerodynamic changes: Average number of breaths
Average number of breaths - counts how many breaths a speaker takes during a speech task. Higher breath counts may reflect inefficient voice use or reduced respiratory support. This data will be collected using the Phonatory Aerodynamic System 6600 (PAS) by PENTAX, a specialized tool for assessing voice aerodynamics. The PAS system uses a mask and microphone setup to capture airflow and sound pressure during structured speech tasks.
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month
Aerodynamic changes: Average speaking duration
Speaking duration is how long it takes the person to speak the entire passage. This data will be collected using the Phonatory Aerodynamic System 6600 (PAS) by PENTAX, a specialized tool for assessing voice aerodynamics. The PAS system uses a mask and microphone setup to capture airflow and sound pressure during structured speech tasks.
Baseline, Post intervention (1 week), 3 month, 6 month, 12 month
Adherence
Practice will be analyzed for frequency of practice per week
Baseline, end of study (12 month)
Practice fidelity
Practice fidelity will be assessed via analysis of audio-recordings for presence/absence of negative practice and type of practice (i.e. conversation, monology, recitation, reading aloud).
Baseline, end of study (12 month)
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
ילד, מבוגר, גיל שלישי
גיל מינימלי למחקר
16 Years
מגדרים מוערכים למחקר
הכל
  • 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

  • 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
Emory University logoאוניברסיטת אמורי
National Institute on Deafness and Other Communication Disorders (NIDCD) logoNational Institute on Deafness and Other Communication Disorders (NIDCD)
הגורם האחראי למחקר
Amanda Gillespie, חוקר ראשי, Associate Professor, Emory University
איש קשר מרכזי למחקר
איש קשר: Amanda Gillespie, PhD, 404-778-3381, [email protected]
1 מיקומי המחקר ב-1 מדינות

Georgia

Emory Voice Center at Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States
Amanda Gillespie, PhD, איש קשר, 404-778-3381, [email protected]
מגייס