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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acid Reflux Disease, Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Pantoprazole


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pantoprazole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between treatment groups with regard to change in sleepiness score (ESS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acid Reflux, Obstructive Sleep Apnea, Daytime Sleepiness