Back to resultsDysphagia in Oculopharyngeal Muscular Dystrophy (OPMD)- Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up (OPMD)
Primary Purpose
Dysphagia
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Upper esophageal sphincter myotomy
Sponsored by
About this trial
This is an interventional supportive care trial for Dysphagia focused on measuring OPMD, dysphagia, Dysphagia severity, Nutritional state, Speech quality, Upper esophageal sphincter myotomy
Eligibility Criteria
Inclusion Criteria:
- heterozygote and homozygote OPMD patients
Exclusion Criteria:
-
Sites / Locations
- Israel National Center for OPMD and Dysphagia, HYMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Mild dysphagia
Severe dysphagia
Arm Description
Outcomes
Primary Outcome Measures
Dysphagia, quality of life. Proper intervention timing in OPMD based on knowledge about the natural history of the feeding difficulty.
Dysphagia, quality of life. Proper intervention timing in OPMD patients is very important and must be based on deep knowledge about the natural history of the feeding difficulty.
Secondary Outcome Measures
Full Information
NCT ID
NCT01167439
First Posted
July 21, 2010
Last Updated
July 21, 2010
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01167439
Brief Title
Dysphagia in Oculopharyngeal Muscular Dystrophy (OPMD)- Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up
Acronym
OPMD
Official Title
Dysphagia in Oculopharyngeal Muscular Dystrophy. Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aimed to review the natural history of dysphagia and dysphonia in OPMD in order to identify the best candidates and the proper timing to perform dysphagia alleviating procedures in both heterozygote and homozygote patients from the large pool of cases with this disease in Israel.
Detailed Description
Clinical evaluation of patients suspected of having OPMD. Genetic confirmatory tests (diagnostic DNA test) at the genetic unit in Afula Hospital. Clinical follow-up with endoscopic fiber optic evaluation of swallowing. Pre-operative assessment. Crycopharyngeal myotomy intervention in selected patients. Nutrition follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
OPMD, dysphagia, Dysphagia severity, Nutritional state, Speech quality, Upper esophageal sphincter myotomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mild dysphagia
Arm Type
No Intervention
Arm Title
Severe dysphagia
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Upper esophageal sphincter myotomy
Intervention Description
Upper esophageal sphincter release operation to allow better swallowing. The intervention is done under GA and by extra-mucosal approach.
Primary Outcome Measure Information:
Title
Dysphagia, quality of life. Proper intervention timing in OPMD based on knowledge about the natural history of the feeding difficulty.
Description
Dysphagia, quality of life. Proper intervention timing in OPMD patients is very important and must be based on deep knowledge about the natural history of the feeding difficulty.
Time Frame
at least 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
heterozygote and homozygote OPMD patients
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergiu C. Blumen, MD
Phone
972-4-630-4262
Facility Information:
Facility Name
Israel National Center for OPMD and Dysphagia, HYMC
City
POB 169, Hadera
ZIP/Postal Code
38100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergiu C. Blumen, MD
Phone
972-52-2645938
Email
navabl@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Dysphagia in Oculopharyngeal Muscular Dystrophy (OPMD)- Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up
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