The Role of Therapy for Muscle Tension Dysphagia | NCT02647931

Studies
The Role of Therapy for Muscle Tension Dysphagia

NCT02647931

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 14, 2018Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Muscle Tension Dysphagia

Interventions

Voice therapy for Muscle Tension Dysphagia

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Mar 2018Actual

Completion Date

Mar 2018Actual

First Submitted Date

Nov 13, 2015

First Submission Date that Met QC Criteria

Jan 5, 2016

First Posted Date

Jan 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2018

Last Update Posted Date

Mar 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Voice Therapy for Muscle Tension Dysphagia	Experimental	Voice therapy for Muscle Tension Dysphagia patients.	Behavioral: Voice therapy for Muscle Tension Dysphagia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Voice therapy for Muscle Tension Dysphagia	Behavioral	Voice therapy for Muscle Tension Dysphagia	Voice Therapy for Muscle Tension Dysphagia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of dysphagia measured via patient self-report measures	Number of participants who report improvement of dysphagia symptoms following therapy.	Duration of therapy, approximately 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Age 18-99
Diagnosed with Muscle Tension Dysphagia

Exclusion Criteria

Physical or emotional disorder preventing the completion of therapy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christina Kang, CCC-SLP	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Arizona		Scottsdale	Arizona	85259	United States