CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Ambulatory voice biofeedbackbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03416829
NCT03416829N/ACompleted
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Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction

Massachusetts General Hospital·interventional·Posted Jan 31, 2018·Updated Nov 14, 2022

In Brief

A clinical study evaluating Ambulatory voice biofeedback for Vocal Fold Nodules. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVocal Fold Nodules
CountriesUnited States
CollaboratorsNational Institute on Deafness and Other Communication Disorders (NIDCD)

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 31, 2018
Enrollment StartSep 27, 2017
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 8.4 years ago

Interventions

Ambulatory voice biofeedbackbehavioral

Subjects will be provided cues regarding their vocal behavior in daily life. The cues will either be: 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly... 25% feedback = a vibrotactile cue on a smartwatch every 4th time the patient voices incorrectly... Summary feedback = the patient's overall compliance (percentage of voiced time within desired limits) will be presented via a smartwatch every 2 minutes of voicing.