Intensive Versus Traditional Voice Therapy

NCT03129880 | Completed

• 4 other identifiers: 2015-0763A539772SMPH/SURGERY/SPEECHProtocol Version 12/2/2020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphonia

Keywords

Voice disorder; Hoarseness; Phonation Disorders; Speech Disorders

Outcome Measures

Primary Outcomes (2)

• 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)

  Baseline compared to Immediately post voice therapy

• 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)

  Baseline compared to 12 weeks post voice therapy

Study Arms (2)

Weekly Voice Therapy

PLACEBO COMPARATOR

Participants are randomized to receiving weekly voice therapy sessions

Behavioral: Weekly Voice Therapy

Intensive Voice Therapy

ACTIVE COMPARATOR

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

Behavioral: Intensive Voice Therapy

Interventions

Weekly Voice Therapy BEHAVIORAL

Participants will be randomized to receive weekly voice therapy

Weekly Voice Therapy

Intensive Voice Therapy BEHAVIORAL

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

Intensive Voice Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison Voice and Swallow Clinic

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Dysphonia; Voice Disorders; Hoarseness; Speech Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Language Disorders; Communication Disorders; Neurobehavioral Manifestations

Study Officials

• Emerald J Doll, MS, CCC-SLP

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 26, 2017
• Study Start: March 13, 2016
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)