Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

Mass General Brigham

Status: Completed

Conditions: Vocal Fold Nodules; Muscle Tension Dysphonia

Treatments: Behavioral: Ambulatory voice biofeedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03416868

2016P002849B

1P50DC015446-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Standard of care voice therapy with ambulatory voice biofeedback.

Experimental group

Description:

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.

Treatment:

Behavioral: Ambulatory voice biofeedback