Gastroesophageal Reflux Disease (GERD)/Nighttime Heartburn and Driving Performance

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David A. Johnson, MD
• Collaborator: AstraZeneca
• Treatments: Esomeprazole

Criteria

Inclusion Criteria:

• 18-60

• Diagnosis of GERD

• Nighttime heartburn

Exclusion Criteria:

• Less than 18 years old or older than 60 years of age

• Any conditions other than GERD that could be the primary cause of or a factor in your sleep disturbance. These include but are not limited to: severe anxiety, severe depression, panic attacks, sleep apnea, blocked airways, chronic pulmonary disease requiring oxygen therapy

• Restless leg syndrome

• Excessive need for nighttime urination (more than 2 times per night)

• Insomnia

• Excessive caffeine use (more than 4 standard 8-oz cups of coffee or caffeinated beverages, or 2 12-oz caffeinated sodas per day) or within 3 hours of sleep time

• Buerger's disease

• Use of a proton pump inhibitor

• Active gastrointestinal bleeding

• Severe, unresolved or unstable illnesses that the investigator feels would interfere with your participation in the study

• Severe liver disease

• Chronic illness that may cause excessive fatigue or low energy level such as chronic fatigue syndrome, or uncontrolled thyroid disease

• Need for anticoagulation therapy such as warfarin

• Active chemo or radiation therapy for cancer

• Prior gastric by-pass surgery

• History of seizures and/or anti-seizure medications (such as phenytoin or mephenytoin)

• Known hypersensitivity to esomeprazole or antacid tablets such as Tums, or Rolaids

• A history of drug addiction or alcohol abuse within the previous year

• Pregnant or lactating

• HIV+ status