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Sponsors and Collaborators: |
University of Cincinnati Wyeth |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00307944 |
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 | Intervention | Phase |
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Acid Reflux Disease Obstructive Sleep Apnea |
Drug: Pantoprazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Randomized, Placebo-Controlled Trial of Pantoprazole for Sleepiness Associated With Acid Reflux and Obstructive Sleep Disordered Breathing |
Estimated Enrollment: | 68 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | August 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
University Ear, Nose and Throat Specialists | |
Cincinnati, Ohio, United States, 45267-0528 |
Principal Investigator: | David L Steward, MD | University Ear, Nose and Throat Specialists |
Study ID Numbers: | 04-06-24-04 |
Study First Received: | March 27, 2006 |
Last Updated: | December 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00307944 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Acid Reflux Obstructive Sleep Apnea Daytime Sleepiness |
Sleep Apnea Syndromes Apnea Gastrointestinal Diseases Pantoprazole Sleep Apnea, Obstructive Respiration Disorders Dyssomnias Sleep Disorders Gastroesophageal Reflux |
Sleep Disorders, Intrinsic Esophageal Motility Disorders Deglutition Disorders Signs and Symptoms Digestive System Diseases Respiratory Tract Diseases Esophageal Disorder Signs and Symptoms, Respiratory Esophageal Diseases |
Sleep Apnea Syndromes Apnea Gastrointestinal Diseases Pantoprazole Nervous System Diseases Sleep Apnea, Obstructive Respiration Disorders Gastrointestinal Agents Sleep Disorders Dyssomnias Gastroesophageal Reflux |
Pharmacologic Actions Sleep Disorders, Intrinsic Esophageal Motility Disorders Deglutition Disorders Signs and Symptoms Digestive System Diseases Respiratory Tract Diseases Therapeutic Uses Anti-Ulcer Agents Signs and Symptoms, Respiratory Esophageal Diseases |