Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

Study Overview
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Brief Summary
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Note that this is the second half of a study under the same IRB and NIH grant. This second study will enroll patients with nodules and those with muscle tension dysphonia. These two groups will receive ambulatory voice biofeedback throughout 6 weeks of voice therapy. The targeted objective voice measure during biofeedback will be individually tailored with the goal of increased percentage compliance.

Detailed Description
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This second study will use a single subject design to determine if adding ambulatory voice biofeedback to conventional voice therapy can result in faster carryover (compliance) of new vocal behaviors established during voice therapy to daily life. Here, ambulatory voice biofeedback will be based on glottal aerodynamic measures that have subject-specific sensitivity to vocal hyperfunction. Hypothesis: The first ambulatory voice biofeedback week will result in higher compliance percentages when compared to baseline and the week prior to the initiation of biofeedback (when there was voice therapy alone). Days/weeks post-AVB will be significantly different than baseline (successful carryover).

Official Title
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Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction

Conditions
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Vocal Fold Nodules, Muscle Tension Dysphonia

Intervention / Treatment
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* Behavioral: Ambulatory voice biofeedback


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Week 3 start<br>For the first two weeks of voice therapy, patients will receive ambulatory voice monitoring (no biofeedback) during their voice therapy sessions and throughout the week. In the following 3 weeks of voice therapy (weeks 3 through 5), patients in this arm will be provided ambulatory voice biofeedback. Week 6 involves monitoring without feedback in all subjects to evaluate washout and any effect of feedback dose. Monitoring per week: 20 minutes of phonation time after the therapy session (Day 1), 40 minutes of phonation time for each of the next consecutive two days (Days 2 and 3), and 40 minutes of phonation time for the day before the patient's subsequent voice therapy session (Day 4). During biofeedback weeks, feedback will be enabled only on Days 1 and 2. | Behavioral: Ambulatory voice biofeedback<br>* Patients will be provided cues regarding their vocal behavior in daily life. Depending on the result of Study 1 in this IRB protocol/NIH grant, 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.<br>|
| Experimental: Week 4 start<br>For the first three weeks of voice therapy, patients will receive ambulatory voice monitoring (no biofeedback) during their voice therapy sessions and throughout the week. In voice therapy weeks 4 and 5, patients in this arm will be provided ambulatory voice biofeedback. Week 6 involves monitoring without feedback in all subjects to evaluate washout and any effect of feedback dose. Monitoring per week: 20 minutes of phonation time after the therapy session (Day 1), 40 minutes of phonation time for each of the next consecutive two days (Days 2 and 3), and 40 minutes of phonation time for the day before the patient's subsequent voice therapy session (Day 4). During biofeedback weeks, feedback will be enabled only on Days 1 and 2. | Behavioral: Ambulatory voice biofeedback<br>* Patients will be provided cues regarding their vocal behavior in daily life. Depending on the result of Study 1 in this IRB protocol/NIH grant, 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.<br>|
| Experimental: Week 5 start<br>For the first four weeks of voice therapy, patients will receive ambulatory voice monitoring (no biofeedback) during their voice therapy sessions and throughout the week. In voice therapy week 5, patients in this arm will be provided ambulatory voice biofeedback. Week 6 involves monitoring without feedback in all subjects to evaluate washout and any effect of feedback dose. Monitoring per week: 20 minutes of phonation time after the therapy session (Day 1), 40 minutes of phonation time for each of the next consecutive two days (Days 2 and 3), and 40 minutes of phonation time for the day before the patient's subsequent voice therapy session (Day 4). During biofeedback weeks, feedback will be enabled only on Days 1 and 2. | Behavioral: Ambulatory voice biofeedback<br>* Patients will be provided cues regarding their vocal behavior in daily life. Depending on the result of Study 1 in this IRB protocol/NIH grant, 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent compliance | 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 | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ambulatory, Biofeedback, Voice