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

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ClinicalTrials.gov Identifier: NCT00669695
Recruitment Status : Terminated (Interim analysis performed without efficient results)
First Posted : April 30, 2008
Last Update Posted : September 24, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Drug: Atorvastatin treatment Other: CPAP device Other: sham CPAP treatment Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
Study Start Date : May 2008
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: sham CPAP


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Evaluation of the inflammation occurring during OSAS. [ Time Frame: after 3 months of Atorvastatin or placebo treatment. ]
  2. Evaluation of the insulin-resistance associated to OSAS. [ Time Frame: after 3 months of Atorvastatin or placebo treatment. ]
  3. Evaluation of the hypercholesterolemia associated to OSAS. [ Time Frame: after 3 months of Atorvastatin or placebo treatment. ]
  4. 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 ]
  5. Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo. [ Time Frame: after 3 months of treatment. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669695


Locations
France
Universitary Hospital of Angers
Angers, France, 49033
Hospital of Annemasse
Annemasse, France, 74017
University Hospital of Grenoble
Grenoble, France, 38043
Switzerland
Universitary Hospital of Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Louis PEPIN, MD, PhD University Hospital of Grenoble, France
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00669695     History of Changes
Other Study ID Numbers: 0721
2007-005286-35 ( Registry Identifier: ID RCB )
First Posted: April 30, 2008    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013

Keywords provided by University Hospital, Grenoble:
statins
cardiovascular risk
Obstructive sleep apnea syndrome (OSAS) patients

Additional relevant MeSH terms:
Syndrome
Inflammation
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors