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Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback

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ClinicalTrials.gov Identifier: NCT03416829
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:
This first study will enroll 3 groups of patients with vocal fold nodules that will receive different schedules of ambulatory voice biofeedback (100% frequency feedback, 25% frequency feedback, summary feedback) to avoid their upper 15th percentile of vocal loudness.

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

Detailed Description:
We will conduct this study (based on principles of motor learning) using novel smartphone-based ambulatory voice biofeedback systems aimed at improving the carryover of newly established vocal behaviors into daily life. This first study will determine which of three types of ambulatory feedback results in better learning/retention (100% frequency, 25% frequency, or delayed summary feedback every 2 minutes of voicing) of a new vocal behavior (reduced vocal intensity) in three groups of 15 patients with vocal fold nodules. Hypothesis: Patients receiving lower frequency or summary feedback will produce lower initial performance but higher short- and long-term retention than patients receiving feedback 100% of the time.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction
Actual Study Start Date : September 27, 2017
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Experimental: 100% frequency
Some patients will be assigned (via block randomization) to receive ambulatory voice biofeedback (100% frequency - vibrotactile cueing every time the participant exceeds a vocal intensity threshold). Voice monitoring will be conducted for 3 days (device automatically turns off after 42 minutes of voicing): Day 1: biofeedback will be active all day , Day 2: the day after Day 1, no biofeedback, just monitoring to test short-term retention. Day 3: 7 days post-Day 1, no biofeedback, just monitoring to test longer-term retention.
Behavioral: Ambulatory voice biofeedback
Subjects will be provided cues regarding their vocal behavior in daily life. 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: 25% frequency
Some patients will be assigned (via block randomization) to receive ambulatory voice biofeedback (25% frequency - vibrotactile cueing every 4th time the participant exceeds a vocal intensity threshold). Voice monitoring will be conducted for 3 days (device automatically turns off after 42 minutes of voicing): Day 1: biofeedback will be active all day , Day 2: the day after Day 1, no biofeedback, just monitoring to test short-term retention. Day 3: 7 days post-Day 1, no biofeedback, just monitoring to test longer-term retention.
Behavioral: Ambulatory voice biofeedback
Subjects will be provided cues regarding their vocal behavior in daily life. 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: Summary feedback
Some patients will be assigned (via block randomization) to receive ambulatory voice biofeedback (summary - no cueing, statistics shown every 2 minutes of voicing). Voice monitoring will be conducted for 3 days (device automatically turns off after 42 minutes of voicing): Day 1: biofeedback will be active all day , Day 2: the day after Day 1, no biofeedback, just monitoring to test short-term retention. Day 3: 7 days post-Day 1, no biofeedback, just monitoring to test longer-term retention.
Behavioral: Ambulatory voice biofeedback
Subjects will be provided cues regarding their vocal behavior in daily life. 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: 1 week ]
    Patients will be told to avoid voicing in their upper 15th percentile of loudness. The percentage compliance is the amount of voicing spent below this threshold.



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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

Exclusion Criteria:

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): NCT03416829


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: NCT03416829    
Other Study ID Numbers: 2016P002849A
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