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

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ClinicalTrials.gov Identifier: NCT01093339
Recruitment Status : Completed
First Posted : March 25, 2010
Last Update Posted : August 19, 2010
Sponsor:
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

Group/Cohort
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.


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01093339


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

Responsible Party: Ronnie Fass MD, SArizona VAHCS
ClinicalTrials.gov Identifier: NCT01093339     History of Changes
Other Study ID Numbers: SLEEP DEPRIVATION
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:
GERD
SLEEP DEPRIVATION
APPETITE REGULATION
GHRELIN
LEPTIN

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