TerminatedNot Applicable

Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome

Stopped: Enrollment difficulty

France40 participantsStarted 2010-10-16

Plain-language summary

The main objective of this study is to evaluate the decrease of inflammation of adipose tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by continuous positive airway pressure (cPAP). An interim analysis will be performed when 40 patients will be included.

Who can participate

Age range

18 Years – 69 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male between 18 and 70 years old * Apnea Hypopnea Index \> 30/h and \> 5% TST with SaO2 \< 90% * patients obese (BMI \> 33kg/m2) or non obese (BMI \< 27kg/m2) Exclusion Criteria: * Female * coronary ischemic disease, past history of CVA * chronic pulmonary disease measured by arterial gasometry (PaO2 \< 60mmHg and/or PaCO2 \> 45mmHg) * known hepatic disease * alcohol consumption \> 3 units/day * sleepiness considered to be dangerous by the investigator * patient having an hazardous work regarding to awareness * patient being under anticoagulant, antiplatelet drug or having an active stent or bleeding disorder * patient having an inflammatory syndrome (C-reactive Protein \> 10) * any allergy to local anaesthetics * chronic muscle pain * contraindication to MRI

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Decrease of inflammation in adipose tissue

Timeframe: 2 months

Trial details

NCT IDNCT01196845

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02-16

View on ClinicalTrials.gov More Decrease of Inflammation of Adipose Tissue trials