Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Randomized, Placebo-Controlled Trial of Pantoprazole for Sleepiness Associated With Acid Reflux and Obstructive Sleep Disordered Breathing|
- Difference between treatment groups with regard to change in sleepiness score (ESS)
- 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).
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307944
|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|