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Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

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ClinicalTrials.gov Identifier: NCT03416868
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Robert E Hillman, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Vocal Fold Nodules Muscle Tension Dysphonia Behavioral: Ambulatory voice biofeedback Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

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.




Primary Outcome Measures :
  1. 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"



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416868


Contacts
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Contact: Robert E Hillman, PhD 617-643-2466 hillman.robert@mgh.harvard.edu
Contact: Jarrad H Van Stan, PhD 617-643-8410 jvanstan@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation Recruiting
Boston, Massachusetts, United States, 02114
Contact: Robert E Hillman, PhD    617-643-2466    hillman.robert@mgh.harvard.edu   
Contact: Jarrad H Van Stan, PhD    617-643-8410    jvanstan@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Robert E Hillman, PhD Mass General Hospital, Harvard, MGH IHP
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Responsible Party: Robert E Hillman, Research Director at the MGH Voice Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03416868    
Other Study ID Numbers: 2016P002849B
1P50DC015446-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert E Hillman, Massachusetts General Hospital:
Ambulatory
Biofeedback
Voice
Additional relevant MeSH terms:
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Dysphonia
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms