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). 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.