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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00307944
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : December 12, 2007
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Cincinnati

Study Description
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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).

Condition or disease Intervention/treatment Phase
Acid Reflux Disease Obstructive Sleep Apnea Drug: Pantoprazole Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled Trial of Pantoprazole for Sleepiness Associated With Acid Reflux and Obstructive Sleep Disordered Breathing
Study Start Date : August 2004
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Sleep Apnea

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Difference between treatment groups with regard to change in sleepiness score (ESS)

Secondary Outcome Measures :
  1. Difference between treatment groups with regard to change in reaction time testing.
  2. Difference between treatment groups with regard to change in total reflux symptom scores.
  3. Difference between treatment groups with regard to change in sleep related QOL (FOSQ).

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307944


Locations
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United States, Ohio
University Ear, Nose and Throat Specialists
Cincinnati, Ohio, United States, 45267-0528
Sponsors and Collaborators
University of Cincinnati
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Principal Investigator: David L Steward, MD University Ear, Nose and Throat Specialists
More Information
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ClinicalTrials.gov Identifier: NCT00307944    
Other Study ID Numbers: 04-06-24-04
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: December 12, 2007
Last Verified: December 2007
Keywords provided by University of Cincinnati:
Acid Reflux
Obstructive Sleep Apnea
Daytime Sleepiness
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleepiness
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action