To Determine if Sleep Deprivation Results in Increased Esophageal Acid Exposure

Gastroesophageal Disease Clinical Trial

— IRUSESOM0428  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093339
• Other study ID #: SLEEP DEPRIVATION
• Status: Completed
• Phase: N/A
• First received: March 24, 2010
• Last updated: August 18, 2010
• Start date: August 2006
• Est. completion date: March 2010

Study information

• Verified date: August 2010
• Source: Southern Arizona VA Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Disease
• Gastroesophageal Reflux
• Sleep Deprivation

Locations

Country	Name	City	State
United States	SArizonaVAHCS	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Southern Arizona VA Health Care System

Country where clinical trial is conducted

United States,