Back to resultsEvaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea
Primary Purpose
Gastroesophageal Reflux, Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous positive airway pressure ventilation
Sponsored by
About this trial
This is an interventional other trial for Gastroesophageal Reflux
Eligibility Criteria
Inclusion Criteria: 18-75 years of age, symptoms consistent with sleep apnea, agree to consent form and placement of pH probes Exclusion Criteria: any unstable medical condition, previous upper gi surgery or anatomic abnormality of upper gi tract, acid suppressing medication
Sites / Locations
- University of Pennsylvania
Outcomes
Primary Outcome Measures
Decrease in GERD symptoms
Patients suffering from Obstructive Sleep Apnea have been shown to suffer from GERD events more frequesntly and with prolonged episodes compared to controls.
Secondary Outcome Measures
Full Information
NCT ID
NCT00194376
First Posted
September 14, 2005
Last Updated
February 16, 2018
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT00194376
Brief Title
Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea
Official Title
Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pennsylvania
4. Oversight
5. Study Description
Brief Summary
Patients with a clinically indicated sleep study will be enrolled in this study. They will have a diagnostic and a therapeutic sleep study with continuous positive airway pressure ventilation. For both studies a pH probe will be placed nasal to measure the amount of acidic reflux during each study. Baseline levels of reflux from the diagnostic sleep study will be compared to reflux episodes while on continuous positive airway pressure ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Sleep Apnea
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Continuous positive airway pressure ventilation
Intervention Description
CPAP ventilation is a therapeutic modality which uses positive pressure of air through a sealed nasal mask to treat a condition known as sleep apnea
Primary Outcome Measure Information:
Title
Decrease in GERD symptoms
Description
Patients suffering from Obstructive Sleep Apnea have been shown to suffer from GERD events more frequesntly and with prolonged episodes compared to controls.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 years of age, symptoms consistent with sleep apnea, agree to consent form and placement of pH probes
Exclusion Criteria:
any unstable medical condition, previous upper gi surgery or anatomic abnormality of upper gi tract, acid suppressing medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Metz, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea
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