- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01079884
Gastroesophageal Reflux Disease (GERD)/Nighttime Heartburn and Driving Performance
February 21, 2012 updated by: David A. Johnson, MD
Gastroesophageal Reflux Disease, Sleep, and the Relationship to Driving Simulator 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 Overview
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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Virginia
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Norfolk, Virginia, United States, 23502
- Digestive and Liver Disease Specialists
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Driving impairment effects measured by the driving simulator (variance of 1.5 feet is abnormal).
Time Frame: 4 weeks
|
All parameters will be assessed by both per protocol and intention to treat assessments.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (ACTUAL)
March 1, 2011
Study Completion (ACTUAL)
March 1, 2011
Study Registration Dates
First Submitted
March 2, 2010
First Submitted That Met QC Criteria
March 2, 2010
First Posted (ESTIMATE)
March 3, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
February 22, 2012
Last Update Submitted That Met QC Criteria
February 21, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRUSESOM0438
- 08-03-FB-0036 (OTHER: IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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