Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

Not Applicable

Completed

• Conditions: Muscle Tension Dysphonia; Vocal Fold Nodules
• Interventions: Behavioral: Ambulatory voice biofeedback

• Registration Number: NCT03416868
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Start: 2018-06-01
• Primary Completion: 2024-01-25
• Study Completion: 2024-02-05
• Results First Submitted: 2024-02-13
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Results First Posted: 2024-04-17
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard of care voice therapy with ambulatory voice biofeedback.	Ambulatory voice biofeedback	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.

Primary Outcome Measures

Name	Time	Method
Percent Compliance	Week 1, Week 2, Week 3	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".

Trial Locations

Locations (1)

Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation; 🇺🇸 Boston, Massachusetts, United States