NCT03416829

Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback

Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vocal Fold Nodules

Interventions

Type	Name	Description
BEHAVIORAL	Ambulatory voice biofeedback	Subjects will be provided cues regarding their vocal behavior in daily life. The cues will either be: 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly... 25% feedback = a vibrotactile cue on a smartwatch every 4th time the patient voices incorrectly... Summary feedback = the patient's overall compliance (percentage of voiced time within desired limits) will be presented via a smartwatch every 2 minutes of voicing.

Timeline

• Start date: 2017-09-27
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2018-01-31
• Last updated: 2022-11-14
• Results posted: 2022-11-14

Locations

1 site across 1 country: United States