Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

NCT03416868 | Completed Results

• 2 other identifiers: 2016P002849B1P50DC015446-01A1
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with vocal hyperfunction will undergo standard of care voice therapy with ambulatory voice monitoring before therapy and after the first 3 voice therapy sessions. Biofeedback will be added to ambulatory monitoring after the 2nd voice therapy session only.

Conditions

Vocal Fold Nodules; Muscle Tension Dysphonia

Keywords

Ambulatory; Biofeedback; Voice

Outcome Measures

Primary Outcomes (1)

• 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".

  Week 1, Week 2, Week 3

Study Arms (1)

Standard of care voice therapy with ambulatory voice biofeedback.

EXPERIMENTAL

Patients with Vocal Hyperfunction will undergo standard of care voice therapy, Ambulatory monitoring will be completed by the patients before therapy and throughout the first 3 weeks of therapy. Specifically, ambulatory monitoring will be worn by the patient for their 4 days with the most voicing during the first 3 weeks of therapy. Biofeedback will be activated only after the 2nd voice therapy session.

Behavioral: Ambulatory voice biofeedback

Interventions

Ambulatory voice biofeedback BEHAVIORAL

Patients will be provided cues regarding their vocal behavior in daily life. Specifically, the patient will receive 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly. The specific objective voice measure for biofeedback will depend upon which measure is most strongly associated with improvements during voice therapy.

Standard of care voice therapy with ambulatory voice biofeedback.

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 or muscle tension dysphonia undergoing voice therapy

You may not qualify if:

• 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.

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 Van Stan, PhD, CCC-SLP
• Organization: Massachusetts General Hospital; Harvard Medical School

jvanstan@mgh.harvard.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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: June 1, 2018
• Primary Completion: January 25, 2024
• Study Completion: February 5, 2024
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)