CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 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/NCT03416868
NCT03416868N/ACompleted
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Preliminary Study 2 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 Apr 17, 2024

In Brief

A clinical study evaluating Ambulatory voice biofeedback for Vocal Fold Nodules and Muscle Tension Dysphonia. Completed, enrolled 39 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 31, 2018
Enrollment StartJun 1, 2018
Primary CompletionJan 25, 2024
Study CompletionFeb 5, 2024
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 8.4 years ago

Interventions

Ambulatory voice biofeedbackbehavioral

Patients will be provided cues regarding their vocal behavior in daily life. Specifically, the patient will receive 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly. The specific objective voice measure for biofeedback will depend upon which measure is most strongly associated with improvements during voice therapy.