Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05970562
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Muscle Tension Dysphonia
  • Vocal Fold Polyp
  • Vocal Nodules in Adults
  • Voice Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ambulatory Voice Monitoring with Biofeedback (AVM-B) — DEVICE
    AVM-B is software on the Voice Health Monitor that uses a neck-placed accelerometer to sense neck skin vibrations during voicing in daily life. The AVM-B consists of cues every time the patient exceeds a subject-specific threshold, \[100% frequency AVM-B\] and/or summary statistics every 2 minutes of voicing \[Summary AVM-B\].
  • Conversation Training Therapy — BEHAVIORAL
    CTT is a 4-week (1 45-minute session per week) evidence-based voice therapy for patients with VH, developed primarily to maximize the amount and speed of generalization outside the therapy session. It consists of 3 required targets: Decreased overall auditory-perceptual voice severity, improved discrimination between baseline and improved voicing, and adherence to CTT recommendations in daily life. The three optional targets are decreased overall auditory-perceptual severity across an increased pitch range, loudness range, and decreased rate of speech. All voice-related targets are modified through practicing voicing with increased forward resonance and mean airflow in spontaneous speech/conversation.

Study Details

Vocal hyperfunction (VH) is the most commonly treated class of voice disorders by speech-language pathologists and voice therapy is the primary curative treatment. Patients and clinicians report that generalizing improved voicing into daily life is the most significant barrier to successful therapy. We will test if extending biofeedback into the patient's daily life using ambulatory voice monitoring will significantly improve generalization during therapy and if individual patient factors, like how easily they can modify their voice and engagement during therapy, moderate the effects of the biofeedback.

Key Dates

Start date
Mar 1, 2024
Status verified
May 2025
Primary completion
Sep 1, 2028
Completion
Apr 1, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Conversation Training Therapy with Ambulatory Voice Biofeedback
    Conversation Training Therapy will be administered one time per week for 1 hour. Ambulatory Voice Monitoring with Biofeedback will be administered during the second therapy session and for 5 days between the second and third therapy sessions.
  • Active Comparator: Conversation Training Therapy alone
    Conversation Training Therapy will be administered one time per week for 1 hour.

Primary Outcome Measure

Generalization [ Time Frame: Before therapy, immediately after therapy, and 6 months after therapy ]

Central Contacts

  • Jarrad Van Stan, PhD, CCC-SLP
    617-643-8410
    [email protected]
  • Robert Hillman, PhD, CCC-SLP
    617-643-2466

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02118
Lauren Tracy, MD
[email protected]
617-638-8124
Massachusetts General HospitalBostonMassachusetts02114
Jarrad Van Stan, PhD, CCC-SLP
[email protected]
617-643-8410

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By research site
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