Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

March 27, 2023 updated by: Robert E Hillman, Massachusetts General Hospital

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

Note that this is the second half of a study under the same IRB and NIH grant. This second study will enroll patients with nodules and those with muscle tension dysphonia. These two groups will receive ambulatory voice biofeedback throughout 6 weeks of voice therapy. The targeted objective voice measure during biofeedback will be individually tailored with the goal of increased percentage compliance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This second study will use a single subject design to determine if adding ambulatory voice biofeedback to conventional voice therapy can result in faster carryover (compliance) of new vocal behaviors established during voice therapy to daily life. Here, ambulatory voice biofeedback will be based on glottal aerodynamic measures that have subject-specific sensitivity to vocal hyperfunction. Hypothesis: The first ambulatory voice biofeedback week will result in higher compliance percentages when compared to baseline and the week prior to the initiation of biofeedback (when there was voice therapy alone). Days/weeks post-AVB will be significantly different than baseline (successful carryover).

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Week 3 start
For the first two weeks of voice therapy, patients will receive ambulatory voice monitoring (no biofeedback) during their voice therapy sessions and throughout the week. In the following 3 weeks of voice therapy (weeks 3 through 5), patients in this arm will be provided ambulatory voice biofeedback. Week 6 involves monitoring without feedback in all subjects to evaluate "washout" and any effect of feedback dose. Monitoring per week: 20 minutes of phonation time after the therapy session (Day 1), 40 minutes of phonation time for each of the next consecutive two days (Days 2 and 3), and 40 minutes of phonation time for the day before the patient's subsequent voice therapy session (Day 4). During biofeedback weeks, feedback will be enabled only on Days 1 and 2.
Behavioral: Ambulatory voice biofeedback
Patients will be provided cues regarding their vocal behavior in daily life. Depending on the result of Study 1 in this IRB protocol/NIH grant, 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.
Experimental: Week 4 start
For the first three weeks of voice therapy, patients will receive ambulatory voice monitoring (no biofeedback) during their voice therapy sessions and throughout the week. In voice therapy weeks 4 and 5, patients in this arm will be provided ambulatory voice biofeedback. Week 6 involves monitoring without feedback in all subjects to evaluate "washout" and any effect of feedback dose. Monitoring per week: 20 minutes of phonation time after the therapy session (Day 1), 40 minutes of phonation time for each of the next consecutive two days (Days 2 and 3), and 40 minutes of phonation time for the day before the patient's subsequent voice therapy session (Day 4). During biofeedback weeks, feedback will be enabled only on Days 1 and 2.
Behavioral: Ambulatory voice biofeedback
Patients will be provided cues regarding their vocal behavior in daily life. Depending on the result of Study 1 in this IRB protocol/NIH grant, 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.
Experimental: Week 5 start
For the first four weeks of voice therapy, patients will receive ambulatory voice monitoring (no biofeedback) during their voice therapy sessions and throughout the week. In voice therapy week 5, patients in this arm will be provided ambulatory voice biofeedback. Week 6 involves monitoring without feedback in all subjects to evaluate "washout" and any effect of feedback dose. Monitoring per week: 20 minutes of phonation time after the therapy session (Day 1), 40 minutes of phonation time for each of the next consecutive two days (Days 2 and 3), and 40 minutes of phonation time for the day before the patient's subsequent voice therapy session (Day 4). During biofeedback weeks, feedback will be enabled only on Days 1 and 2.
Behavioral: Ambulatory voice biofeedback
Patients will be provided cues regarding their vocal behavior in daily life. Depending on the result of Study 1 in this IRB protocol/NIH grant, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent compliance
Time Frame: 6 weeks
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"
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Robert E Hillman, PhD, Mass General Hospital, Harvard, MGH IHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P002849B
  • 1P50DC015446-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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