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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atorvastatin treatment
CPAP device
sham CPAP treatment
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring statins, cardiovascular risk, Obstructive sleep apnea syndrome (OSAS) patients

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitary Hospital of Angers
  • Hospital of Annemasse
  • University Hospital of Grenoble
  • Universitary Hospital of Geneva

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Sham Comparator

Active Comparator

Arm Label

Stat/CPAP

Stat/sham CPAP

Placebo/CPAP

Placebo/sham CPAP

Arm Description

Atorvastatin and CPAP treatments

Atorvastatin and sham CPAP treatments

Placebo and CPAP treatments

Placebo and sham CPAP treatments

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of the inflammation occurring during OSAS.
Evaluation of the insulin-resistance associated to OSAS.
Evaluation of the hypercholesterolemia associated to OSAS.
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.
Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.

Full Information

First Posted
April 21, 2008
Last Updated
September 23, 2013
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT00669695
Brief Title
Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
Acronym
StatinflaSAS
Official Title
Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis performed without efficient results
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
statins, cardiovascular risk, Obstructive sleep apnea syndrome (OSAS) patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stat/CPAP
Arm Type
Placebo Comparator
Arm Description
Atorvastatin and CPAP treatments
Arm Title
Stat/sham CPAP
Arm Type
Placebo Comparator
Arm Description
Atorvastatin and sham CPAP treatments
Arm Title
Placebo/CPAP
Arm Type
Sham Comparator
Arm Description
Placebo and CPAP treatments
Arm Title
Placebo/sham CPAP
Arm Type
Active Comparator
Arm Description
Placebo and sham CPAP treatments
Intervention Type
Drug
Intervention Name(s)
Atorvastatin treatment
Other Intervention Name(s)
statin
Intervention Description
Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.
Intervention Type
Other
Intervention Name(s)
CPAP device
Other Intervention Name(s)
positive air way pressure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham CPAP treatment
Other Intervention Name(s)
sham CPAP
Intervention Description
This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluation of the inflammation occurring during OSAS.
Time Frame
after 3 months of Atorvastatin or placebo treatment.
Title
Evaluation of the insulin-resistance associated to OSAS.
Time Frame
after 3 months of Atorvastatin or placebo treatment.
Title
Evaluation of the hypercholesterolemia associated to OSAS.
Time Frame
after 3 months of Atorvastatin or placebo treatment.
Title
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
Title
Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.
Time Frame
after 3 months of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis PEPIN, MD, PhD
Organizational Affiliation
University Hospital of Grenoble, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitary Hospital of Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Hospital of Annemasse
City
Annemasse
ZIP/Postal Code
74017
Country
France
Facility Name
University Hospital of Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Universitary Hospital of Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16337480
Citation
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.
Results Reference
background
PubMed Identifier
26567858
Citation
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.
Results Reference
derived
PubMed Identifier
25221387
Citation
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.
Results Reference
derived

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Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

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