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

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 Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Acid Reflux Disease
• Intervention / Treatment: Drug: Pantoprazole

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.

• Study Type: Interventional
• Enrollment: 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0528
      • University Ear, Nose and Throat Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Study Completion: August 1, 2006

Study Registration Dates

• First Submitted: March 27, 2006
• First Submitted That Met QC Criteria: March 27, 2006
• First Posted (ESTIMATE): March 28, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2007
• Last Update Submitted That Met QC Criteria: December 10, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Acid Reflux; Daytime Sleepiness
• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Signs and Symptoms, Respiratory; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Gastroesophageal Reflux; Esophagitis, Peptic; Sleepiness; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: 04-06-24-04