Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

Muscle Tension Dysphonia Clinical Trial

Official title:

Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416868
• Other study ID #: 2016P002849B
• Secondary ID: 1P50DC015446-01A
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: February 5, 2024

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will use a single subject design to determine if adding ambulatory voice biofeedback to conventional voice therapy can result in faster carryover (generalization) of new vocal behaviors established during voice therapy to daily life. Here, ambulatory voice biofeedback will be based on objective measures that have subject-specific sensitivity to vocal hyperfunction. Hypothesis: The ambulatory voice biofeedback week (week 2) will result in higher generalization percentages when compared to baseline and the week prior to the initiation of biofeedback (week 1). This effect will be retained when the biofeedback is removed (week 3), thus it will be different than baseline and week 1, but not different than week 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 5, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysphonia
• Muscle Tension Dysphonia
• Vocal Fold Nodules

Intervention

Behavioral:
• Ambulatory voice biofeedback
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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