To Determine if Sleep Deprivation Results in Increased Esophageal Acid Exposure

NCT ID: NCT01093339

Last Updated: 2010-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroesophageal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No treatment

Subjects w/ condition and subjects w/o condition of GERD (gastroesophageal reflux disease)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Southern Arizona VA Health Care System

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SArizona VAHCS

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ronnie Fass, MD

Role: PRINCIPAL_INVESTIGATOR

SArizona VAHCS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SArizonaVAHCS

Tucson, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SLEEP DEPRIVATION

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Home Sleep and Metabolism
NCT02253368 COMPLETED NA
Chronic Sleep Restriction
NCT01493661 COMPLETED