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

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.

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Key information

Conditions

Gastroesophageal Reflux Apnea Deglutition Disorders Digestive System Diseases Dyssomnias Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous positive airway pressure ventilation

Procedure

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 outcomes

Decrease in GERD symptoms

Time frame: 24 hours

Patients suffering from Obstructive Sleep Apnea have been shown to suffer from GERD events more frequesntly and with prolonged episodes compared to controls.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2007
First posted: Sep 19, 2005
Registry last updated: Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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