Acid Reflux Disease, Obstructive Sleep Apnea
Conditions
Keywords
Acid Reflux, Obstructive Sleep Apnea, Daytime Sleepiness
Brief 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).
Detailed 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.
Interventions
DRUGPantoprazole
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between treatment groups with regard to change in sleepiness score (ESS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
United States
Outcome results
None listed