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NCT03416868 · ClinicalTrials.gov registry record · NA
Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback
A NA study of Muscle Tension Dysphonia and Vocal Fold Nodules, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT03416868: Completed NA study of Muscle Tension Dysphonia and Vocal Fold Nodules, sponsored by Massachusetts General Hospital.
NCT03416868 is a NA study of Muscle Tension Dysphonia and Vocal Fold Nodules that has completed, run by Massachusetts General Hospital. The registered enrollment target is 39 participants, below the 285-participant average among 4 other Muscle Tension Dysphonia trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03416868, a NA study of Muscle Tension Dysphonia and Vocal Fold Nodules, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with vocal hyperfunction will undergo standard of care voice therapy with ambulatory voice monitoring before therapy and after the first 3 voice therapy sessions. Biofeedback will be added to ambulatory monitoring after the 2nd voice therapy session only.
Primary Outcome
Using a patient-specific voice measure, patients will be asked to avoid crossing numeric thresholds. The amount of voicing spent within desired thresholds will be the "percent compliance".
Conditions Studied
Interventions
- BEHAVIORAL Ambulatory voice biofeedback
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2024-02-05 |
| Phase | NA |
What the finished NCT03416868 record still lists
NCT03416868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 285-participant average among 4 other Muscle Tension Dysphonia trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Muscle Tension Dysphonia appearing as the primary indexed condition, and to 1 intervention - of which Ambulatory voice biofeedback is the first listed.
NCT03416868 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03416868 about?
NCT03416868 is a clinical study titled "Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback". Patients with vocal hyperfunction will undergo standard of care voice therapy with ambulatory voice monitoring before therapy and after the first 3 voice therapy sessions. Biofeedback will be added to ambulatory monitoring after the 2nd voice therapy session only.
What is the current status of trial NCT03416868?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2018-06-01. Estimated completion is 2024-02-05.
What conditions does trial NCT03416868 study?
This clinical trial studies the following conditions: Muscle Tension Dysphonia, Vocal Fold Nodules.
What interventions are being tested in trial NCT03416868?
The interventions under investigation include: Ambulatory voice biofeedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT03416868?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03416868 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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