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Intensive Versus Traditional Voice Therapy

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ClinicalTrials.gov Identifier: NCT03129880
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dysphonia Behavioral: Weekly Voice Therapy Behavioral: Intensive Voice Therapy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Voice-related Outcomes in Response to Intensive Versus Traditional Therapy Programs
Actual Study Start Date : March 13, 2016
Estimated Primary Completion Date : March 12, 2023
Estimated Study Completion Date : March 12, 2023
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Weekly Voice Therapy
Participants are randomized to receiving weekly voice therapy sessions
 Behavioral: Weekly Voice Therapy
Participants will be randomized to receive weekly voice therapy
Active Comparator: Intensive Voice Therapy
Participants are randomized to receiving multiple sessions of voice therapy in one day
 Behavioral: Intensive Voice Therapy
Participants will be randomized to receive multiple sessions of voice therapy in one day.


Outcome Measures
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Primary Outcome Measures :
  1. Self-efficacy and readiness scale Changes [ Time Frame: Baseline compared to Immediately post voice therapy ]
    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)

  2. Self-efficacy and readiness scale Change [ Time Frame: Baseline compared to 12 weeks post voice therapy ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129880


Contacts
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Contact: Emerald J Doll, MS, CCC-SLP 608-262-5213 ext 6082625213 doll@surgery.wisc.edu
Contact: Mary J Lynch, BA 608-263-4864 ext 6082634864 lynchm@surgery.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin-Madison Voice and Swallow Clinic Recruiting
Madison, Wisconsin, United States, 53792
Contact: Emerald Doll, MS    608-262-5213    doll@surgery.wsic.edu   
Contact: Mary Lynch, BA    608-263-4864 ext 6082634864    lynchm@surgery.wisc.edu   
Principal Investigator: Emerald Doll, MS         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Emerald J Doll, MS, CCC-SLP University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03129880    
Other Study ID Numbers: 2015-0763
A539772 ( Other Identifier: UW Madison )
SMPH/SURGERY/SPEECH ( Other Identifier: UW Madison )
Protocol Version 12/2/2020 ( Other Identifier: Minimal Risk IRB (Health Sciences), UW Madison )
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Voice disorder
Hoarseness
Phonation Disorders
Speech Disorders
Additional relevant MeSH terms:
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Dysphonia
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases