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

This study has been completed.
Information provided by:
Southern Arizona VA Health Care System Identifier:
First received: March 24, 2010
Last updated: August 18, 2010
Last verified: August 2010
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.

Gastroesophageal Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Southern Arizona VA Health Care System:

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

Enrollment: 50
Study Start Date: August 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
No treatment
Subjects w/ condition and subjects w/o condition of GERD (gastroesophageal reflux 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).

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
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Ronnie Fass MD, SArizona VAHCS Identifier: NCT01093339     History of Changes
Study First Received: March 24, 2010
Last Updated: August 18, 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 processed this record on September 19, 2017