Back to resultsThe Role of Therapy for Muscle Tension Dysphagia
Primary Purpose
Muscle Tension Dysphagia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Voice therapy for Muscle Tension Dysphagia
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Tension Dysphagia
Eligibility Criteria
Inclusion Criteria
- Age 18-99
- Diagnosed with Muscle Tension Dysphagia
Exclusion Criteria
- Physical or emotional disorder preventing the completion of therapy
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Voice Therapy for Muscle Tension Dysphagia
Arm Description
Voice therapy for Muscle Tension Dysphagia patients.
Outcomes
Primary Outcome Measures
Improvement of dysphagia measured via patient self-report measures
Number of participants who report improvement of dysphagia symptoms following therapy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02647931
Brief Title
The Role of Therapy for Muscle Tension Dysphagia
Official Title
Muscle Tension Dysphagia Treatment Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Muscle tension dysphagia is a novel diagnostic taxonomy describing a subset of patient population with reported dysphagia who exhibit normal oropharyngeal and esophageal swallowing function as evidenced by videofluoroscopic swallow study. These patients also demonstrate abnormal supraglottic muscle tension during laryngoscopy as well as signs of laryngeal hypersensitivity and laryngopharyngeal reflux. Treatment of these patients with Proton Pump Inhibitor (PPI) therapy is a common practice however voice therapy invention targeting the unloading of the supraglottic muscle tension has been shown to be highly effective in symptom resolution per the investigators' clinical experience. The study is designed to answer efficacy of treatment being offered to patients with muscle tension dysphagia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tension Dysphagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Voice Therapy for Muscle Tension Dysphagia
Arm Type
Experimental
Arm Description
Voice therapy for Muscle Tension Dysphagia patients.
Intervention Type
Behavioral
Intervention Name(s)
Voice therapy for Muscle Tension Dysphagia
Intervention Description
Voice therapy for Muscle Tension Dysphagia
Primary Outcome Measure Information:
Title
Improvement of dysphagia measured via patient self-report measures
Description
Number of participants who report improvement of dysphagia symptoms following therapy.
Time Frame
Duration of therapy, approximately 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Age 18-99
Diagnosed with Muscle Tension Dysphagia
Exclusion Criteria
Physical or emotional disorder preventing the completion of therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Kang, CCC-SLP
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Role of Therapy for Muscle Tension Dysphagia
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