Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback

NCT03416829 | Completed Results

• 2 other identifiers: 2016P002849A1P50DC015446-01A1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Vocal Fold Nodules

Keywords

Ambulatory; Biofeedback; Voice

Outcome Measures

Primary Outcomes (1)

• Percent Compliance

  Percentage compliance is the amount of voiced time patients spent below their biofeedback threshold divided by the total amount of voiced time. Each patient's biofeedback threshold was individually established as their 85th percentile of vocal intensity. Patients were asked to avoid loud voicing, i.e., anything at their 85th percentile or higher. During biofeedback, patients were cued every time (100% frequency) or every 4th time (25% frequency) the voiced louder than their 85th percentile; or provided summary information (their percentage compliance) after every 2 minutes of voicing (summary feedback). During short-term retention monitoring, patients were asked to not voice loud (over or equal to 85th percentile) the next day and the biofeedback was turned off. During long-term retention monitoring, patients were asked to not voice loud one week later without biofeedback.

  1 week

Study Arms (3)

100% frequency

EXPERIMENTAL

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

25% frequency

EXPERIMENTAL

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

Summary feedback

EXPERIMENTAL

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

Interventions

Ambulatory voice biofeedback BEHAVIORAL

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.

100% frequency; 25% frequency; Summary feedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with vocal fold nodules

You may not qualify if:

• Non-English speakers are excluded because prompts on the smartphone app are only available in English

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation

Boston, Massachusetts, 02114, United States

Location

Results Point of Contact

• Title: Jarrad H Van Stan
• Organization: Massachusetts General Hospital

jvanstan@mghihp.edu

617-643-8410

Study Officials

• Robert E Hillman, PhD

  Mass General Hospital, Harvard, MGH IHP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director at the MGH Voice Center

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: September 27, 2017
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)