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

This study has been completed.
Sponsor:
Information provided by:
Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier:
NCT01093339
First received: March 24, 2010
Last updated: August 18, 2010
Last verified: August 2010
  Purpose

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
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)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ronnie Fass MD, SArizona VAHCS
ClinicalTrials.gov Identifier: NCT01093339     History of Changes
Other Study ID Numbers: SLEEP DEPRIVATION
Study First Received: March 24, 2010
Last Updated: August 18, 2010
Health Authority: United States: Federal Government

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 Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014