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)