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Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

Primary Purpose

Vocal Fold Nodules, Muscle Tension Dysphonia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ambulatory voice biofeedback
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vocal Fold Nodules focused on measuring Ambulatory, Biofeedback, Voice

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital - Center for Laryngeal Surgery and Voice RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Week 3 start

Week 4 start

Week 5 start

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Percent compliance
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"

Secondary Outcome Measures

Full Information

First Posted
January 24, 2018
Last Updated
March 27, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT03416868
Brief Title
Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback
Official Title
Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Fold Nodules, Muscle Tension Dysphonia
Keywords
Ambulatory, Biofeedback, Voice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Week 3 start
Arm Type
Experimental
Arm Description
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.
Arm Title
Week 4 start
Arm Type
Experimental
Arm Description
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.
Arm Title
Week 5 start
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ambulatory voice biofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent compliance
Description
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"
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert E Hillman, PhD
Phone
617-643-2466
Email
hillman.robert@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jarrad H Van Stan, PhD
Phone
617-643-8410
Email
jvanstan@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert E Hillman, PhD
Organizational Affiliation
Mass General Hospital, Harvard, MGH IHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert E Hillman, PhD
Phone
617-643-2466
Email
hillman.robert@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jarrad H Van Stan, PhD
Phone
617-643-8410
Email
jvanstan@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

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