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NCT03416829 · ClinicalTrials.gov registry record · NA
Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback
A NA study of Vocal Fold Nodules, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT03416829: Completed NA study of Vocal Fold Nodules, sponsored by Massachusetts General Hospital.
NCT03416829 is a NA study of Vocal Fold Nodules that has completed, run by Massachusetts General Hospital. The registered enrollment target is 29 participants, below the 55-participant average among 3 other Vocal Fold Nodules trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03416829, a NA study of Vocal Fold Nodules, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
This first study will enroll 3 groups of patients with vocal fold nodules that will receive different schedules of ambulatory voice biofeedback (100% frequency feedback, 25% frequency feedback, summary feedback) to avoid their upper 15th percentile of vocal loudness.
Primary Outcome
Percentage compliance is the amount of voiced time patients spent below their biofeedback threshold divided by the total amount of voiced time. Each patient's biofeedback threshold was individually established as their 85th percentile of vocal intensity. Patients were asked to avoid loud voicing, i.e., anything at their 85th percentile or higher. During biofeedback, patients were cued every time (100% frequency) or every 4th time (25% frequency) the voiced louder than their 85th percentile; or p
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 | 29 participants |
| Start Date | 2017-09-27 |
| Est. Completion | 2022-06-30 |
| Phase | NA |
What the finished NCT03416829 record still lists
NCT03416829 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 55-participant average among 3 other Vocal Fold Nodules trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Vocal Fold Nodules appearing as the primary indexed condition, and to 1 intervention - of which Ambulatory voice biofeedback is the first listed.
NCT03416829 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03416829 about?
NCT03416829 is a clinical study titled "Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback". This first study will enroll 3 groups of patients with vocal fold nodules that will receive different schedules of ambulatory voice biofeedback (100% frequency feedback, 25% frequency feedback, summary feedback) to avoid their upper 15th percentile of vocal loudness.
What is the current status of trial NCT03416829?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2017-09-27. Estimated completion is 2022-06-30.
What conditions does trial NCT03416829 study?
This clinical trial studies the following conditions: Vocal Fold Nodules.
What interventions are being tested in trial NCT03416829?
The interventions under investigation include: Ambulatory voice biofeedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT03416829?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03416829 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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