Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

NCT00669695 | Terminated Phase 2 DMC

• 2 other identifiers: 07212007-005286-35
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 4

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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

statins; cardiovascular risk; Obstructive sleep apnea syndrome (OSAS) patients

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the percent of peripheral arterial tone (PAT) improvement in comparison with the baseline situation.

  after 3 months of Atorvastatin treatment.

Secondary Outcomes (5)

• Evaluation of the inflammation occurring during OSAS.

  after 3 months of Atorvastatin or placebo treatment.

• Evaluation of the insulin-resistance associated to OSAS.

  after 3 months of Atorvastatin or placebo treatment.

• Evaluation of the hypercholesterolemia associated to OSAS.

  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.

  after 6 months of treatments

• Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.

  after 3 months of treatment.

Study Arms (4)

Stat/CPAP

PLACEBO COMPARATOR

Atorvastatin and CPAP treatments

Drug: Atorvastatin treatment; Other: CPAP device

Stat/sham CPAP

PLACEBO COMPARATOR

Atorvastatin and sham CPAP treatments

Drug: Atorvastatin treatment; Other: sham CPAP treatment

Placebo/CPAP

SHAM COMPARATOR

Placebo and CPAP treatments

Other: CPAP device

Placebo/sham CPAP

ACTIVE COMPARATOR

Placebo and sham CPAP treatments

Other: sham CPAP treatment

Interventions

Atorvastatin treatment DRUG

Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.

Also known as: statin

Stat/CPAP; Stat/sham CPAP

CPAP device OTHER

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.

Also known as: positive air way pressure

Placebo/CPAP; Stat/CPAP

sham CPAP treatment OTHER

This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.

Also known as: sham CPAP

Placebo/sham CPAP; Stat/sham CPAP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Potentially dangerous sleepiness
• Jobs at risk

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (4)

Universitary Hospital of Angers

Angers, 49033, France

Location

Hospital of Annemasse

Annemasse, 74017, France

Location

University Hospital of Grenoble

Grenoble, 38043, France

Location

Universitary Hospital of Geneva

Geneva, 1211, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 16337480 BACKGROUND

• 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.

  PMID: 26567858 DERIVED

• 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.

  PMID: 25221387 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Jean-Louis PEPIN, MD, PhD

  University Hospital of Grenoble, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 30, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

CH (1); FR (3)