Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback

Not Applicable

Completed

• Conditions: Vocal Fold Nodules

• Registration Number: NCT03416829
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

We will conduct this study (based on principles of motor learning) using novel smartphone-based ambulatory voice biofeedback systems aimed at improving the carryover of newly established vocal behaviors into daily life. This first study will determine which of three types of ambulatory feedback results in better learning/retention (100% frequency, 25% frequency, or delayed summary feedback every 2 minutes of voicing) of a new vocal behavior (reduced vocal intensity) in three groups of 15 patients with vocal fold nodules. Hypothesis: Patients receiving lower frequency or summary feedback will produce lower initial performance but higher short- and long-term retention than patients receiving feedback 100% of the time.

Study Timeline

• Study Start: 2017-09-27
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Results First Submitted: 2022-08-22
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-20
• Last Update Submitted: 2022-10-20
• Results First Posted: 2022-11-14
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Patients with vocal fold nodules

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent Compliance	1 week	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.

Trial Locations

Locations (1)

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