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NCT05970562 · ClinicalTrials.gov registry record · Early Phase 1
Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction
A Early Phase 1 study of Voice Disorders and Muscle Tension Dysphonia, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT05970562: Recruiting Early Phase 1 study of Voice Disorders and Muscle Tension Dysphonia, sponsored by Massachusetts General Hospital.
NCT05970562 is a Early Phase 1 study of Voice Disorders and Muscle Tension Dysphonia that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 100 participants, above the 82-participant average among 7 other Voice Disorders trials with a reported enrollment target (22% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05970562, a Early Phase 1 study of Voice Disorders and Muscle Tension Dysphonia, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study Summary
Vocal hyperfunction (VH) is the most commonly treated class of voice disorders by speech-language pathologists and voice therapy is the primary curative treatment. Patients and clinicians report that generalizing improved voicing into daily life is the most significant barrier to successful therapy. We will test if extending biofeedback into the patient's daily life using ambulatory voice monitoring will significantly improve generalization during therapy and if individual patient factors, like how easily they can modify their voice and engagement during therapy, moderate the effects of the biofeedback.
Primary Outcome
Generalization will be represented as a "percent accuracy" where voiced frames of a feature that are above or below a percentile threshold (based on baseline/pre-therapy monitoring data) are divided by the total number of voiced frames.
Conditions Studied
Interventions
- DEVICE Ambulatory Voice Monitoring with Biofeedback (AVM-B)
- BEHAVIORAL Conversation Training Therapy
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2029-04-01 |
| Phase | Early Phase 1 |
What NCT05970562 shows while recruiting
NCT05970562 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 82-participant average among 7 other Voice Disorders trials with a reported enrollment target (22% higher).
The record links to 4 conditions, with Voice Disorders appearing as the primary indexed condition, and to 2 interventions - of which Ambulatory Voice Monitoring with Biofeedback (AVM-B) is the first listed.
NCT05970562 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05970562 about?
NCT05970562 is a clinical study titled "Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction". Vocal hyperfunction (VH) is the most commonly treated class of voice disorders by speech-language pathologists and voice therapy is the primary curative treatment. Patients and clinicians report that generalizing improved voicing into daily life is the most significant barrier to successful therapy....
What is the current status of trial NCT05970562?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 100 participants. The study started on 2024-03-01. Estimated completion is 2029-04-01.
What conditions does trial NCT05970562 study?
This clinical trial studies the following conditions: Voice Disorders, Muscle Tension Dysphonia, Vocal Fold Polyp, Vocal Nodules in Adults.
What interventions are being tested in trial NCT05970562?
The interventions under investigation include: Ambulatory Voice Monitoring with Biofeedback (AVM-B) (DEVICE), Conversation Training Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT05970562?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05970562 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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