Gastroesophageal DiseaseIRUSESOM0428NCT01093339
To Determine if Sleep Deprivation Results in Increased Esophageal Acid Exposure
An observational study of Gastroesophageal Disease, run by Southern Arizona VA Health Care System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Disease
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 subjects w/ GERD 25 subjects w/o GERD
Who may be able to join
- Male/Female - 18-80
- 2 or more episodes of heartburn a week for last 3 months
Who cannot join
- 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.
Show all 12Show fewer
- Diabetes Mellitus
- Neuropathy
- Seizures
- Sleep Apnea
- Co-morbidity that interfere w/sleep
- Women who are pregnant, or childbearing yrs, not on BC
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Gastroesophageal Disease
- Keywords
- GERD, SLEEP DEPRIVATION, APPETITE REGULATION, GHRELIN, LEPTIN
- Medical subject headings
- Gastroesophageal Reflux, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Subjects w/ condition and subjects w/o condition of GERD (gastroesophageal reflux disease) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startAug 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Arizona VA Health Care System
- Sponsor type
- US federal agency
- Investigators
- Ronnie Fass, MD, Principal investigator, SArizona VAHCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093339
- Sponsor's protocol ID
- SLEEP DEPRIVATION
- Acronym
- IRUSESOM0428
- Status last verified
- Aug 2010
- First submitted
- 24 Mar 2010
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01093339
- Acronym / sponsor ID
- IRUSESOM0428 / SLEEP DEPRIVATION
- Conditions
- Gastroesophageal Disease
- Keywords
- GERD, SLEEP DEPRIVATION, APPETITE REGULATION, GHRELIN, LEPTIN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Southern Arizona VA Health Care SystemUS federal agency
- Study start
- Aug 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | –Subjects w/ condition and subjects w/o condition of GERD (gastroesophageal reflux disease) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 subjects w/ GERD 25 subjects w/o GERD
Key inclusion criteria (2 listed)
- Male/Female - 18-80
- 2 or more episodes of heartburn a week for last 3 months
Key exclusion criteria (12 listed)
- Previous upper GI surgery
- Underlying co-morbidity
- Narcotic medications
- Psychotropic's and Benzodiazapines medications
- Hx of psychological abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronnie Fass, MD principal investigator
SArizona VAHCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Disease, run by Southern Arizona VA Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2010.