Official Title: “Randomized, Placebo-Controlled Trial of Pantoprazole for Sleepiness Associated With Acid Reflux and Obstructive Sleep Disordered Breathing”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Pantoprazole

Primary Measures

• Difference between treatment groups with regard to change in sleepiness score (ESS)

Secondary Measures

• Difference between treatment groups with regard to change in reaction time testing.
• Difference between treatment groups with regard to change in total reflux symptom scores.
• Difference between treatment groups with regard to change in sleep related QOL (FOSQ).

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Cincinnati

Overall Clinical Trial Officials and Contacts

David L Steward, MD Principal Investigator University Ear, Nose and Throat Specialists  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00307944

Study ID Number: 04-06-24-04

ClinicalTrials.gov Identifier: NCT00307944

Health Authority: United States: Food and Drug Administration