Intensive Versus Traditional Voice Therapy

NCT ID: NCT03129880

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-13

Study Completion Date

2024-03-12

Brief Summary

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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

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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.

Conditions

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Dysphonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Weekly Voice Therapy

Participants are randomized to receiving weekly voice therapy sessions

Group Type PLACEBO_COMPARATOR

Weekly Voice Therapy

Intervention Type BEHAVIORAL

Participants will be randomized to receive weekly voice therapy

Intensive Voice Therapy

Participants are randomized to receiving multiple sessions of voice therapy in one day

Group Type ACTIVE_COMPARATOR

Intensive Voice Therapy

Intervention Type BEHAVIORAL

Participants will be randomized to receive multiple sessions of voice therapy in one day.

Interventions

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Weekly Voice Therapy

Participants will be randomized to receive weekly voice therapy

Intervention Type BEHAVIORAL

Intensive Voice Therapy

Participants will be randomized to receive multiple sessions of voice therapy in one day.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emerald J Doll, MS, CCC-SLP

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin-Madison Voice and Swallow Clinic

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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A539772

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/SURGERY/SPEECH

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 12/2/2020

Identifier Type: OTHER

Identifier Source: secondary_id

2015-0763

Identifier Type: -

Identifier Source: org_study_id

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