To Determine if Sleep Deprivation Results in Increased Esophageal Acid Exposure (IRUSESOM0428)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01093339
Recruitment Status : Completed
First Posted : March 25, 2010
Last Update Posted : August 19, 2010
Information provided by:
Southern Arizona VA Health Care System

Brief Summary:
The purpose of this study is to determine if sleep deprivation results in increased esophageal acid exposure in healthy controls and gastroesophageal reflux disease (GERD) patients.

Condition or disease
Gastroesophageal Disease

Detailed Description:
To determine if increased esophageal acid exposure is mediated by altering appetite regulation. To assess if there is any relationship between sleep deprivation and the serum level of TNF-alfa (a protein that can be elevated in inflammation).

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: To Determine if Sleep Deprivation Results in Increased Esophageal Acid Exposure, and if This Effect is Mediated in Gastroesophageal Reflux Disease (GERD)Patients by Altering Appetite Regulation
Study Start Date : August 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

No treatment
Subjects w/ condition and subjects w/o condition of GERD (gastroesophageal reflux disease)

Biospecimen Retention:   Samples Without DNA
Serum samples collected and stored -80 freezer in GI lab.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
25 subjects w/ GERD 25 subjects w/o GERD

Inclusion Criteria:

  • Male/Female - 18-80
  • 2 or more episodes of heartburn a week for last 3 months

Exclusion Criteria:

  • Previous upper GI surgery
  • Underlying co-morbidity
  • Narcotic medications
  • Psychotropic's and Benzodiazapines medications
  • Hx of psychological abnormalities
  • Hx of ETOH in previous 6 mos.
  • Diabetes Mellitus
  • Neuropathy
  • Seizures
  • Sleep Apnea
  • Co-morbidity that interfere w/sleep
  • Women who are pregnant, or childbearing yrs, not on BC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01093339

United States, Arizona
Tucson, Arizona, United States, 85723
Sponsors and Collaborators
Southern Arizona VA Health Care System
Principal Investigator: Ronnie Fass, MD SArizona VAHCS

Responsible Party: Ronnie Fass MD, SArizona VAHCS Identifier: NCT01093339     History of Changes
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: August 19, 2010
Last Verified: August 2010

Keywords provided by Southern Arizona VA Health Care System:

Additional relevant MeSH terms:
Gastroesophageal Reflux
Sleep Deprivation
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders