Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin (StatinflaSAS)

September 23, 2013 updated by: University Hospital, Grenoble

The aim of this clinical trial is to evaluate the effect of Atorvastatin on the endothelial function improvement during the obstructive sleep apnea syndrome (OSAS) after 3 months of treatment, by a double-blind, randomized, placebo-controlled, multi-center study.

An interim analysis will be performed when 25 patients per group will be included.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Secondary objectives of this clinical trial :

  • 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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • Universitary Hospital of Angers
      • Annemasse, France, 74017
        • Hospital of Annemasse
      • Grenoble, France, 38043
        • University hospital of Grenoble
  • Switzerland
      • Geneva, Switzerland, 1211
        • Universitary Hospital of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women > 18 years old
  • 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:

  • Patients with a history of prior stroke or coronary ischemic disease
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Stat/CPAP
Atorvastatin and CPAP treatments
Drug: Atorvastatin treatment
Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.
Other Names:
  • statin
Other: 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.
Other Names:
  • positive air way pressure
Placebo Comparator: Stat/sham CPAP
Atorvastatin and sham CPAP treatments
Drug: Atorvastatin treatment
Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.
Other Names:
  • statin
Other: 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 Names:
  • sham CPAP
Sham Comparator: Placebo/CPAP
Placebo and CPAP treatments
Other: 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.
Other Names:
  • positive air way pressure
Active Comparator: Placebo/sham CPAP
Placebo and sham CPAP treatments
Other: 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 Names:
  • sham CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint is the percent of peripheral arterial tone (PAT) improvement in comparison with the baseline situation.
Time Frame: after 3 months of Atorvastatin treatment.
after 3 months of Atorvastatin treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the inflammation occurring during OSAS.
Time Frame: after 3 months of Atorvastatin or placebo treatment.
after 3 months of Atorvastatin or placebo treatment.
Evaluation of the insulin-resistance associated to OSAS.
Time Frame: after 3 months of Atorvastatin or placebo treatment.
after 3 months of Atorvastatin or placebo treatment.
Evaluation of the hypercholesterolemia associated to OSAS.
Time Frame: after 3 months of Atorvastatin or placebo treatment.
after 3 months of Atorvastatin or placebo treatment.
Evaluation of the effect of continuous positive airway pressure (CPAP) + Atorvastatin association on the previously cited parameters, in comparison with effect of Atorvastatin, CPAP and placebo.
Time Frame: after 6 months of treatments
after 6 months of treatments
Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.
Time Frame: after 3 months of treatment.
after 3 months of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Louis Pépin, MD, PhD, University Hospital of Grenoble, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 28, 2008

First Posted (Estimate)

April 30, 2008

Study Record Updates

Last Update Posted (Estimate)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0721
  • 2007-005286-35 (Registry Identifier: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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