Gastroesophageal Reflux Disease (GERD)/Nighttime Heartburn and Driving Performance
The implications of sleep as it relates to the physiology and pathogenesis of a number of diseases has until recently been ignored. With the evolution of sleep laboratories, there is an emerging recognition of the relationship between sleep and various gastrointestinal diseases- in particular gastroesophageal reflux disease (GERD).( 1-5) It seems intuitive that waking/daytime activities or events may affect sleep and that any consequent sleep dysfunction may reciprocally further affect daytime function
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Gastroesophageal Reflux Disease, Sleep, and the Relationship to Driving Simulator Performance|
- Driving impairment effects measured by the driving simulator (variance of 1.5 feet is abnormal). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]All parameters will be assessed by both per protocol and intention to treat assessments.
|Study Start Date:||July 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Drug: esomeprazole 40 mg
The implications of sleep as it relates to the physiology and pathogenesis of a number of diseases has until recently been ignored. With the evolution of sleep laboratories, there is an emerging recognition of the relationship between sleep and various gastrointestinal diseases in particular gastroesophageal reflux disease (GERD). Twenty five (25) patients meeting entry criteria will be compared with 25 matching historical control patients who do not have GERD symptoms or sleep disturbance. Patients will record heartburn symptoms and GERD-associated sleep disturbances on a diary card. These patients will be evaluated for baseline functionality GERD symptom scores, PSQI, driving simulator, bed partner questionnaire (optional) and receive 40 mg daily of Nexium® for 4 weeks. Primary outcome variable driving simulator performance will be the relief of nighttime heartburn during the last 7 days of the trial as recorded by the patient on a diary card. Secondary outcome variables include change from baseline to week 4 in the PSQI score, percentage of patients with complete resolution of sleep disturbances, relief of sleep disturbances, and percentage of days without GERD-associated sleep disturbances. Assessment of patients with complete resolution of daytime, night times, and 24-hour heartburn symptoms, and the percentage of patients with relief of daytime and 24-hour heartburn symptoms. The driving simulator performance will be compared at baseline and after 4 weeks of therapy with Nexium®. Also, where available, the bed partner PSQI will be compared at baseline and following treatment of the primary patient with Nexium® for 4 weeks.