Sleep ApneaNCT00395590
Polymorphisms in Inflammatory Cytokines Genes in Subjects With Obstructive Sleep Apnea
An observational study of Sleep Apnea, run by Shaare Zedek Medical Center.
Trial summary
Obstructive sleep apnea is a common sleep disorder. It is known to be related with increased body mass, abdominal obesity, insulin resistance and hypertension. It is currently believed to be a feature of the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Nov 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients attending the sleep apnea clinic for evaluation
Who cannot join
- patients known to have inflammatory conditions
Trial locations and contacts
No sites are listed yet.
Gheona Altarescu contact
About this study
Official title: A Cross Sectional Study of Patients With Obstructive Sleep Apnea for Polymorphisms in Genes of Inflammatory Cytokines.
Obstructive sleep apnea is a common sleep disorder. It is known to be related with increased body mass, abdominal obesity, insulin resistance and hypertension. It is currently believed to be a feature of the metabolic syndrome. Other features of the metabolic syndrome-such as insulin resistace were found related to inflammation and inflammatory cytokines. Several polymorphisms in the genes that encode interleukin 6,inteleukin 10 and TNF-alpha have significant influence on the amounts of cytokine production. we thus hypothesize that polymorphisms related to increased pruduction are more common in subjects with OSA than in matched controls
Read the detailed description
Patients attending a sleep apnea clinic for evluation will be recruited. Patients found positive for OSA will be compared to the patients with a negative study for OSA for the prevalence of polymorphisms in genes of inflammatory cytokines and cytokine levels
- Conditions
- Sleep Apnea
- Keywords
- OSA inflammatory cytokines, metabolic syndrome
- Medical subject headings
- Sleep Apnea Syndromes, Metabolic Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startNov 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Defined population
- Time perspective
- Other
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- mates mates, MD, Study director, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395590
- Sponsor's protocol ID
- 5594ctil
- Status last verified
- Feb 2005
- First submitted
- 2 Nov 2006
- Last updated
- 3 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Study of Patients With Obstructive Sleep Apnea for Polymorphisms in Genes of Inflammatory Cytokines.
- ClinicalTrials.gov ID
- NCT00395590
- Acronym / sponsor ID
- 5594ctil
- Conditions
- Sleep Apnea
- Keywords
- OSA inflammatory cytokines, metabolic syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Nov 2007
- First posted
- 3 Nov 2006 (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.
Obstructive sleep apnea is a common sleep disorder. It is known to be related with increased body mass, abdominal obesity, insulin resistance and hypertension. It is currently believed to be a feature of the metabolic syndrome. Other features of the metabolic syndrome-such as insulin resistace were found related to inflammation and inflammatory cytokines. Several polymorphisms in the genes that encode interleukin 6,inteleukin 10 and TNF-alpha have significant influence on the amounts of cytokine production. we thus hypothesize that polymorphisms related to increased pruduction are more common in subjects with OSA than in matched controls
Detailed description
Patients attending a sleep apnea clinic for evluation will be recruited. Patients found positive for OSA will be compared to the patients with a negative study for OSA for the prevalence of polymorphisms in genes of inflammatory cytokines and cytokine levels
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients attending the sleep apnea clinic for evaluation
Key exclusion criteria (1 listed)
- patients known to have inflammatory conditions
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2006.
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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.
Gheona Altarescu contact
mates mates, MD study director
Ben-Gurion University of the Negev
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by Shaare Zedek Medical Center.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact michal mates, MD (02-6555111 ext. 55650, rheum@szmc.org.il), or a site near the patient. 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 3 Nov 2006.