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Online Voice Education + Vocal Hygiene for Hoarseness

N/A
Recruiting
Led By Aaron Johnson, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with dysphonia with a recommended treatment of voice therapy
Age >18 years
Must not have
Diagnosis of Parkinson's Disease or other neurodegenerative, progressive disorder (e.g., ALS)
Patients who undergo surgical intervention during the course of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) visit, 8 - 10 week visit
Awards & highlights

Summary

This trial is testing whether adding educational online modules to voice therapy can help improve outcomes by increasing patient engagement and understanding.

Who is the study for?
This trial is for English-speaking adults over 18 with hoarseness (dysphonia) who are recommended voice therapy. They must have internet access and be willing to complete all assessments. It's not for those with certain neurological conditions, moderate-to-profound hearing loss, visual impairments that prevent online module completion, or previous voice quality rating training.Check my eligibility
What is being tested?
The study tests if adding educational online modules about voice quality and vocal hygiene can improve patient engagement in voice therapy. The goal is to see if this approach helps patients better understand their treatment plan and potentially leads to better attendance and outcomes in therapy.See study design
What are the potential side effects?
Since the interventions involve educational modules rather than medical treatments, there are no direct physical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with voice disorders and advised to undergo voice therapy.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Parkinson's Disease or another progressive neurodegenerative disorder.
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I will have surgery as part of my treatment plan.
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I have severe hearing loss or am deaf, which may prevent me from participating.
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I am unable to understand and give consent for treatment.
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I have no health issues preventing me from joining voice therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) visit, 8 - 10 week visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) visit, 8 - 10 week visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of Online education module acceptance across the 3 groups
Change of voice handicap perception across the 3 groups
Secondary outcome measures
Change of patient's perception on voice therapy
Change of perceived effectiveness of voice therapy
Change of perceptual voice ratings

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Experimental GroupExperimental Treatment1 Intervention
Participants will complete an online module with content focusing on patient self-rating of vocal quality within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session;
Group II: Control groupActive Control1 Intervention
Participants will not complete an online module. The groups will be compared in terms of attendance, self-efficacy, and treatment outcome measures based on the data collected within the NYU Voice Center standard of care
Group III: Sham Control GroupPlacebo Group1 Intervention
Participants will complete an online module within 24 hours of evaluation, approximately 1-2 weeks prior to their first therapy session, and within 24 hours after each therapy session with content focusing on vocal hygiene.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
847,998 Total Patients Enrolled
1 Trials studying Hoarseness
8 Patients Enrolled for Hoarseness
Aaron Johnson, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Online Voice quality education module Clinical Trial Eligibility Overview. Trial Name: NCT05237648 — N/A
Hoarseness Research Study Groups: Experimental Group, Control group, Sham Control Group
Hoarseness Clinical Trial 2023: Online Voice quality education module Highlights & Side Effects. Trial Name: NCT05237648 — N/A
Online Voice quality education module 2023 Treatment Timeline for Medical Study. Trial Name: NCT05237648 — N/A
~45 spots leftby Jul 2025
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