- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02647931
The Role of Therapy for Muscle Tension Dysphagia
March 12, 2018 updated by: David G. Lott, M.D., Mayo Clinic
Muscle Tension Dysphagia Treatment Efficacy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Age 18-99
- Diagnosed with Muscle Tension Dysphagia
Exclusion Criteria
- Physical or emotional disorder preventing the completion of therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Voice Therapy for Muscle Tension Dysphagia
Voice therapy for Muscle Tension Dysphagia patients.
|
Voice therapy for Muscle Tension Dysphagia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement of dysphagia measured via patient self-report measures
Time Frame: Duration of therapy, approximately 2 months
|
Number of participants who report improvement of dysphagia symptoms following therapy.
|
Duration of therapy, approximately 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christina Kang, CCC-SLP, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
November 13, 2015
First Submitted That Met QC Criteria
January 5, 2016
First Posted (Estimate)
January 6, 2016
Study Record Updates
Last Update Posted (Actual)
March 14, 2018
Last Update Submitted That Met QC Criteria
March 12, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-006933
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.