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

Completed · Not applicable

Conditions studied: GERD

In brief

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

Key facts

Study ID

NCT01079884

Run by

David A. Johnson, MD

People needed

18

Starts

2008-07-01

Expected to finish

2011-03-01

Last updated by the study team

2012-02-22

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-60
• Diagnosis of GERD
• Nighttime heartburn

You may not qualify if…

• 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

Where it is running

• Digestive and Liver Disease Specialists — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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