Overview

Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine if using Pantoprazole decreases your daytime sleepiness and improves your reaction time when compared to using a placebo (sugar pill).
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Cincinnati
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Pantoprazole
Criteria
Inclusion Criteria:

- Age 18 or older

- Daytime sleepiness (ESS >= 8)

- Mild to moderate OSD (AHI<=30)

- Symptoms of GERD

- Symptoms of acid reflux

Exclusion Criteria:

- Pregnant or trying to become pregnant

- Depression or unstable psychiatric disorder

- Allergy to Pantoprazole

- Taking a proton pump inhibitor within the last month

- Taking a histamine-2 receptor blocker within the last month

- Automobile or industrial accident due to daytime sleepiness

- Currently taking ketoconazole, itraconazole, ampicillin or iron salts

- Hypersecretory acid disorder (Zollinger-Ellison Syndrome)

- Active peptic ulcer disease

- Severe concomitant disease of another major body system

- Malignancy in the past 5 years

- Current abuse of alcohol, medication or drugs

- Sedative medications

- Additional treatment for obstructive sleep apnea (i.e. CPAP or surgery)