N/A
N=39
Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback
Vocal Fold Nodules · Muscle Tension Dysphonia
Bottom Line
View on ClinicalTrials.gov: NCT03416868 ↗Enrolled (actual)
39
Serious AEs
—
Results posted
Apr 2024
Primary outcome: Primary: Percent Compliance — 89.04; 92.44; 90.76 percentage of voicing crossing 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
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Compliance |
89.04; 92.44; 90.76 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03416868). 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.