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

GERD Clinical Trial

Official title:

Gastroesophageal Reflux Disease, Sleep, and the Relationship to Driving Simulator Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079884
• Other study ID #: IRUSESOM0438
• Secondary ID: 08-03-FB-0036
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: February 21, 2012
• Start date: July 2008
• Est. completion date: March 2011

Study information

• Verified date: February 2012
• Source: Digestive & Liver Disease Specialists
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Drug:
• esomeprazole 40 mg
40 mg daily for 4 weeks

Locations

Country	Name	City	State
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
David A. Johnson, MD	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving impairment effects measured by the driving simulator (variance of 1.5 feet is abnormal).	All parameters will be assessed by both per protocol and intention to treat assessments.	4 weeks	No