Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea
Information source: University of Cincinnati
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acid Reflux Disease; Obstructive Sleep Apnea
Intervention: Pantoprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
David L Steward, MD, Principal Investigator, Affiliation: University Ear, Nose and Throat Specialists
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).
Clinical Details
Official title: Randomized, Placebo-Controlled Trial of Pantoprazole for Sleepiness Associated With Acid Reflux and Obstructive Sleep Disordered Breathing
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Difference between treatment groups with regard to change in sleepiness score (ESS)
Secondary outcome: 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).
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
University Ear, Nose and Throat Specialists, Cincinnati, Ohio 45267-0528, United States
Additional Information
Starting date: August 2004
Ending date: August 2006
Last updated: December 10, 2007
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