Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome (ADISAS)

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Decrease of Inflammation of Adipose Tissue; Sleep Apnea Syndrome

Treatments: Device: cPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01196845

09-CHUG-25

2009-A00826-51 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Inflammation of adipose tissue will be evaluated by RT-PCR on mRNA of pro and anti-inflammatory cytokines (IL-1, IL-6, IL-4, IL-10, IL-12, RANTES, TNFa, leptin, adiponectin, CD68).

Enrollment: 40 patients

Sex: Male

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

obese + cPAP

Other group

Description:

Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.

Treatment:

Device: cPAP

Device: cPAP

Device: cPAP

Device: cPAP

obese + Sham cPAP

Other group

Description:

Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.

Treatment:

Device: cPAP

Device: cPAP

Device: cPAP

Device: cPAP

non-obese + cPAP

Other group

Description:

Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.

Treatment:

Device: cPAP

Device: cPAP

Device: cPAP

Device: cPAP

non-obese + Sham cPAP

Other group

Description:

Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP.

Treatment:

Device: cPAP

Device: cPAP

Device: cPAP

Device: cPAP