Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
NCT ID: NCT00669695
Last Updated: 2013-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
54 participants
INTERVENTIONAL
2008-05-31
2013-02-28
Brief Summary
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An interim analysis will be performed when 25 patients per group will be included.
Detailed Description
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* To evaluate the effect of Atorvastatin in comparison with the placebo on the inflammation occurring during OSAS, after 3 months of treatment.
* To evaluate the effect of Atorvastatin in comparison with the placebo on the insulin-resistance associated to OSAS, after 3 months of treatment.
* To evaluate the effect of Atorvastatin in comparison with the placebo on the hypercholesterolemia associated to OSAS, after 3 months of treatment.
* To evaluate at 6 months, the effect of the continuous positive airway pressure (CPAP) + Atorvastatin association on the previously cited parameters, in comparison with Atorvastatin, CPAP and placebo.
* To measure the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo, after 3 months of treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Stat/CPAP
Atorvastatin and CPAP treatments
Atorvastatin treatment
Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.
CPAP device
This device consists in a nasal continuous positive airway pressure (CPAP). It will be applied 3 months after the beginning of drug treatment and for 3 months.
Stat/sham CPAP
Atorvastatin and sham CPAP treatments
Atorvastatin treatment
Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.
sham CPAP treatment
This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
Placebo/CPAP
Placebo and CPAP treatments
CPAP device
This device consists in a nasal continuous positive airway pressure (CPAP). It will be applied 3 months after the beginning of drug treatment and for 3 months.
Placebo/sham CPAP
Placebo and sham CPAP treatments
sham CPAP treatment
This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
Interventions
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Atorvastatin treatment
Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.
CPAP device
This device consists in a nasal continuous positive airway pressure (CPAP). It will be applied 3 months after the beginning of drug treatment and for 3 months.
sham CPAP treatment
This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects diagnosed with OSAS (apnea/hypopnea index = AHI \> 30/h)
* Subjects with clinical ATH from grade I or II controlled with mono-therapy(140\<SAP\<180 mmHg and 90\<DAP\<110 mmHg)
Exclusion Criteria
* Chronic respiratory disease (PaO2 \< 60 mmHg and/or PaCO2 \> 45 mmHg)
* Lung disease
* Hypothyroidism
* Statin treatment
* Antihypertensive treatment with more than one drug
* Pregnant or lactating women
* Alcohol consumption \> 3 units/day
* Treatment by itraconazole, ketoconazole, antiprotease, fibrates, antivitamin K, diltiazem, verapamil, erythromycin, clarithromycin, cyclosporin.
* Hypersensitivity to one of the drug compounds
* Patients with modified concomitant treatments during the 3 months before inclusion
* Potentially dangerous sleepiness
* Jobs at risk
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean-Louis PEPIN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Grenoble, France
Locations
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Universitary Hospital of Angers
Angers, , France
Hospital of Annemasse
Annemasse, , France
University Hospital of Grenoble
Grenoble, , France
Universitary Hospital of Geneva
Geneva, , Switzerland
Countries
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References
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Bergeron C, Kimoff J, Hamid Q. Obstructive sleep apnea syndrome and inflammation. J Allergy Clin Immunol. 2005 Dec;116(6):1393-6. doi: 10.1016/j.jaci.2005.10.008. No abstract available.
Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16.
Joyeux-Faure M, Tamisier R, Baguet JP, Dias-Domingos S, Perrig S, Leftheriotis G, Janssens JP, Trzepizur W, Launois SH, Stanke-Labesque F, Levy PA, Gagnadoux F, Pepin JL. Response to statin therapy in obstructive sleep apnea syndrome: a multicenter randomized controlled trial. Mediators Inflamm. 2014;2014:423120. doi: 10.1155/2014/423120. Epub 2014 Aug 25.
Other Identifiers
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2007-005286-35
Identifier Type: REGISTRY
Identifier Source: secondary_id
0721
Identifier Type: -
Identifier Source: org_study_id