NCT01093339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
Last Updated

August 19, 2010

Status Verified

August 1, 2010

Enrollment Period

3.6 years

First QC Date

March 24, 2010

Last Update Submit

August 18, 2010

Conditions

Gastroesophageal Disease

Keywords

GERDSLEEP DEPRIVATIONAPPETITE REGULATIONGHRELINLEPTIN

Study Arms (1)

No treatment

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

25 subjects w/ GERD 25 subjects w/o GERD

You may qualify if:

  • Male/Female - 18-80
  • or more episodes of heartburn a week for last 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SArizonaVAHCS

Tucson, Arizona, 85723, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples collected and stored -80 freezer in GI lab.

MeSH Terms

Conditions

Gastroesophageal RefluxSleep Deprivation

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Ronnie Fass, MD

    SArizona VAHCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 25, 2010

Study Start

August 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

August 19, 2010

Record last verified: 2010-08

Locations

US(1)