N/A
N=29
Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback
Vocal Fold Nodules
Bottom Line
View on ClinicalTrials.gov: NCT03416829 ↗Enrolled (actual)
29
Serious AEs
—
Results posted
Nov 2022
Primary outcome: Primary: Percent Compliance — 97.38; 95.11; 94.44; 96.08 Percentage of voicing below a threshold
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ambulatory voice biofeedback (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Compliance |
97.38; 95.11; 94.44; 96.08; 88.86; 90.48 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03416829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.