Intensive Versus Traditional Voice Therapy
Primary Purpose
Dysphonia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weekly Voice Therapy
Intensive Voice Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dysphonia focused on measuring Voice disorder, Hoarseness, Phonation Disorders, Speech Disorders
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with a Voice disorder
- Diagnosed with benign vocal fold lesions and/or hyper-function
- First/primary propose treatment modality is voice therapy
- Patients who are appropriate for either standard of care treatment modality (traditional or intensive voice therapy)
- Willingness to participate in either standard of care treatment modality
- All races
- Males and females
- English speaking
Exclusion Criteria:
- Younger than 18
- Inability or unwillingness to participate in one of the standard of care treatment modalities
- Laryngeal Surgery or procedures during course of study
- Prisoners
Sites / Locations
- University of Wisconsin-Madison Voice and Swallow ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Weekly Voice Therapy
Intensive Voice Therapy
Arm Description
Participants are randomized to receiving weekly voice therapy sessions
Participants are randomized to receiving multiple sessions of voice therapy in one day
Outcomes
Primary Outcome Measures
Self-efficacy and readiness scale Changes
Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
Self-efficacy and readiness scale Change
Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
Secondary Outcome Measures
Full Information
NCT ID
NCT03129880
First Posted
April 18, 2017
Last Updated
February 15, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT03129880
Brief Title
Intensive Versus Traditional Voice Therapy
Official Title
Voice-related Outcomes in Response to Intensive Versus Traditional Therapy Programs
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2016 (Actual)
Primary Completion Date
March 12, 2024 (Anticipated)
Study Completion Date
March 12, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if there are differences in treatment outcomes between traditional voice therapy, performed weekly for a maximum of 6 weeks versus intensive voice therapy, consisting of 4-6 therapy sessions performed within one day.
Detailed Description
The goal of voice therapy is optimal long-term vocal quality and communication function with minimal recurrence. Traditional voice therapy for dysphonia typically consists of one to two therapy sessions each week with a single clinician for about 8 weeks. Another approach of voice therapy is intensive short-term therapy also known as "boot camp." This approach, borrows from the disciplines of neurobiology, exercise physiology, motor learning, and psychotherapy which describe desirable learning and behavior changes influenced by practice that involves high-intensity overload, variability, and specificity of training. A few studies have showed that "Boot Camp" model of intensive therapy resulted in comparable gains in voice quality and vibratory mechanics and may promote better patient satisfaction and attendance.
While such findings support the notion that intensive voice therapy may enhance voice therapy outcomes, no study to date has examined patient response to the "Boot Camp" approach to voice therapy. The investigators will compare the outcomes of traditional, weekly voice therapy and intensive voice therapy with multiple sessions in one day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphonia
Keywords
Voice disorder, Hoarseness, Phonation Disorders, Speech Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
For purposes of this study participants will be randomized into one of the following two groups:
4-6 weekly standard of care therapy sessions, once a week, for a maximum of six weeks 4-6 standard of care therapy sessions in one day Standard of care treatment may continue past patient enrollment in this study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Weekly Voice Therapy
Arm Type
Placebo Comparator
Arm Description
Participants are randomized to receiving weekly voice therapy sessions
Arm Title
Intensive Voice Therapy
Arm Type
Active Comparator
Arm Description
Participants are randomized to receiving multiple sessions of voice therapy in one day
Intervention Type
Behavioral
Intervention Name(s)
Weekly Voice Therapy
Intervention Description
Participants will be randomized to receive weekly voice therapy
Intervention Type
Behavioral
Intervention Name(s)
Intensive Voice Therapy
Intervention Description
Participants will be randomized to receive multiple sessions of voice therapy in one day.
Primary Outcome Measure Information:
Title
Self-efficacy and readiness scale Changes
Description
Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
Time Frame
Baseline compared to Immediately post voice therapy
Title
Self-efficacy and readiness scale Change
Description
Pre to Post difference in participant's self-efficacy for voice practice and healthy voice technique between therapy groups and within subsets of subjects - readiness ruler of 0 (not at all) to 10 (extremely)
Time Frame
Baseline compared to 12 weeks post voice therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with a Voice disorder
Diagnosed with benign vocal fold lesions and/or hyper-function
First/primary propose treatment modality is voice therapy
Patients who are appropriate for either standard of care treatment modality (traditional or intensive voice therapy)
Willingness to participate in either standard of care treatment modality
All races
Males and females
English speaking
Exclusion Criteria:
Younger than 18
Inability or unwillingness to participate in one of the standard of care treatment modalities
Laryngeal Surgery or procedures during course of study
Prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emerald J Doll, MS, CCC-SLP
Phone
608-262-5213
Email
edoll@uwhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Maddie Baranek, BS
Phone
608-263-4864
Email
baranek@surgery.wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emerald J Doll, MS, CCC-SLP
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison Voice and Swallow Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emerald Doll, MS
Phone
608-262-5213
Email
edoll@uwhealth.org
First Name & Middle Initial & Last Name & Degree
Maddie Baranek, BS
Phone
608-263-4864
Email
baranek@surgery.wisc.edu
First Name & Middle Initial & Last Name & Degree
Emerald Doll, MS
12. IPD Sharing Statement
Plan to Share IPD
No
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Intensive Versus Traditional Voice Therapy
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