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

University of Cincinnati

Status and phase: Completed; Phase 4

Conditions: Acid Reflux Disease; Obstructive Sleep Apnea

Treatments: Drug: Pantoprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00307944

04-06-24-04

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind