To Determine if Sleep Deprivation Results in Increased Es... | NCT01093339

Studies
To Determine if Sleep Deprivation Results in Increased Esophageal Acid Exposure

NCT01093339

Sponsor

Southern Arizona VA Health Care System

Status

Completed

Last Update Posted

Aug 19, 2010Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Gastroesophageal Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Mar 24, 2010

First Submission Date that Met QC Criteria

Mar 24, 2010

First Posted Date

Mar 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2010

Last Update Posted Date

Aug 19, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No treatment		Subjects w/ condition and subjects w/o condition of GERD (gastroesophageal reflux disease)

Interventions

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

25 subjects w/ GERD 25 subjects w/o GERD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ronnie Fass, MD	SArizona VAHCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SArizonaVAHCS		Tucson	Arizona	85723	United States

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux
D012892	Sleep Deprivation

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided