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NCT00194376 Clinical Trial

Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea

Sleep Apnea Clinical Trial

Official title:
Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00194376
Other study ID # 802805
Secondary ID
Status Completed
Phase N/A
First received September 14, 2005
Last updated February 16, 2018
Start date June 2005
Est. completion date June 2007

Study information
Verified date February 2018
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date June 2007
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Continuous positive airway pressure ventilation
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

Locations
Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 24 hours
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