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Clinical Trials/NCT03416868
NCT03416868
Completed
N/A

Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction

Massachusetts General Hospital1 site in 1 country39 target enrollmentJune 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vocal Fold Nodules
Sponsor
Massachusetts General Hospital
Enrollment
39
Locations
1
Primary Endpoint
Percent Compliance
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Detailed Description

This study will use a single subject design to determine if adding ambulatory voice biofeedback to conventional voice therapy can result in faster carryover (generalization) of new vocal behaviors established during voice therapy to daily life. Here, ambulatory voice biofeedback will be based on objective measures that have subject-specific sensitivity to vocal hyperfunction. Hypothesis: The ambulatory voice biofeedback week (week 2) will result in higher generalization percentages when compared to baseline and the week prior to the initiation of biofeedback (week 1). This effect will be retained when the biofeedback is removed (week 3), thus it will be different than baseline and week 1, but not different than week 2.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
February 5, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert E Hillman

Research Director at the MGH Voice Center

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with vocal fold nodules or muscle tension dysphonia undergoing voice therapy

Exclusion Criteria

  • If a patient's baseline ambulatory monitoring data is not at least 1 standard deviation away from a normative database in any measure, he/she will be excluded. Non-English speakers are excluded because prompts on the smartphone app are only available in English.

Outcomes

Primary Outcomes

Percent Compliance

Time Frame: Week 1, Week 2, Week 3

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".

Study Sites (1)

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