Back to resultsEvaluation of Swallowing in Patients With Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
clinical, endoscopical and manometric evaluation
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea, Obstructive focused on measuring Sleep apnea, obstructive, Deglutition Disorders, Manometry, Endoscopy
Eligibility Criteria
Inclusion Criteria:
- diagnosis of obstructive sleep apnea syndrome
Exclusion Criteria:
- other causes of dysphagia
- pharyngeal surgery
- prior treatment for obstructive sleep apnea
Sites / Locations
- Instituto de Assistência Médica ao Servidor Público Estadual
Outcomes
Primary Outcome Measures
Clinical evaluation of swallowing in obstructive sleep apnea
Secondary Outcome Measures
Manometric evaluation of swallowing in obstructive sleep apnea
Endoscopic evaluation of swallowing in obstructive sleep apnea
Full Information
NCT ID
NCT01335594
First Posted
April 11, 2011
Last Updated
April 7, 2012
Sponsor
Luciana Almeida Moreira da Paz Oliveira
1. Study Identification
Unique Protocol Identification Number
NCT01335594
Brief Title
Evaluation of Swallowing in Patients With Obstructive Sleep Apnea
Official Title
Clinical, Endoscopical and Manometric Evaluation of Swallowing in Obstructive Sleep Apnea Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luciana Almeida Moreira da Paz Oliveira
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Sleep apnea, obstructive, Deglutition Disorders, Manometry, Endoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
clinical, endoscopical and manometric evaluation
Intervention Description
clinical evaluation: questionnaire endoscopical analysis manometry
Primary Outcome Measure Information:
Title
Clinical evaluation of swallowing in obstructive sleep apnea
Time Frame
within the first 3 months after diagnostic
Secondary Outcome Measure Information:
Title
Manometric evaluation of swallowing in obstructive sleep apnea
Time Frame
within the first 3 months after diagnostic
Title
Endoscopic evaluation of swallowing in obstructive sleep apnea
Time Frame
within the first 3 months after diagnostic
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of obstructive sleep apnea syndrome
Exclusion Criteria:
other causes of dysphagia
pharyngeal surgery
prior treatment for obstructive sleep apnea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana A M da Paz Oliveira
Organizational Affiliation
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Assistência Médica ao Servidor Público Estadual
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Swallowing in Patients With Obstructive Sleep Apnea
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