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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
David A. Johnson, MD, Digestive & Liver Disease Specialists
ClinicalTrials.gov Identifier:
NCT01079884
First received: March 2, 2010
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention
GERD
Drug: esomeprazole 40 mg

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Digestive & Liver Disease Specialists:

Primary Outcome Measures:
  • 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.


Enrollment: 18
Study Start Date: July 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: esomeprazole 40 mg
    40 mg daily for 4 weeks
    Other Name: Nexium
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079884

Locations
United States, Virginia
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
David A. Johnson, MD
AstraZeneca
  More Information

No publications provided

Responsible Party: David A. Johnson, MD, MD, Digestive & Liver Disease Specialists
ClinicalTrials.gov Identifier: NCT01079884     History of Changes
Other Study ID Numbers: IRUSESOM0438, 08-03-FB-0036
Study First Received: March 2, 2010
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014