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

Posted: March 27, 2006
Identifier: NCT00307944
Purpose: 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).
Sponsors: University of Cincinnati
Wyeth
Provider: University of Cincinnati
Contact: Colleen Eigel, BS, 513-558-1719, Colleen.Eigel@uc.edu
Conditions: Acid Reflux Disease, Obstructive Sleep Apnea
Eligibility: Genders Eligible for Study: Both
Minimum Age Requirement: 18 Years
Maximum Age Requirement: N/A
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)
Description:   Half of the patients enrolled in the study will begin the study taking Pantoprazole. The
other half will begin the study taking a placebo (sugar pill). There is an equal chance of
being placed in either group.

After two weeks, the patients will stop taking their first batch of medication to allow it
to completely leave their bodies. Then the patients will begin taking the other medication
so that by the end of the study, each patient will have been treated with pantoprazole for
two weeks and placebo for two weeks.

At the end of each two weeks, patients will be asked to complete questionnaires regarding
their daytime sleepiness and reflux symptoms. Patients will also complete reaction time
testing as a measure of daytime sleepiness.

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