Obstructive Sleep Apnea SyndromePhase 2StatinflaSASNCT00669695
Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
A Phase 2 study testing Atorvastatin treatment and CPAP device in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Grenoble at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Atorvastatin treatment and CPAP device
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2008to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Universitary Hospital of Angers
Angers, 49033
Hospital of Annemasse
Annemasse, 74017
University Hospital of Grenoble
Grenoble, 38043
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Atorvastatin treatment, CPAP device, sham CPAP treatment
- Keywords
- statins, cardiovascular risk, Obstructive sleep apnea syndrome (OSAS) patients
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin treatmentDrug
Also called statin
Atorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months.
CPAP deviceOther
Also called positive air way pressure
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 treatmentOther
Also called sham CPAP
This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Stat/CPAP | Placebo comparator | Atorvastatin and CPAP treatments Receives: Drug: Atorvastatin treatment; Other: CPAP device |
| Stat/sham CPAP | Placebo comparator | Atorvastatin and sham CPAP treatments Receives: Drug: Atorvastatin treatment; Other: sham CPAP treatment |
| Placebo/CPAP | Sham comparator | Placebo and CPAP treatments Receives: Other: CPAP device |
| Placebo/sham CPAP | Active comparator | Placebo and sham CPAP treatments Receives: Other: sham CPAP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the percent of peripheral arterial tone (PAT) improvement in comparison with the baseline situation.
Measured: after 3 months of Atorvastatin treatment.
Secondary outcomes (5)
Evaluation of the inflammation occurring during OSAS.
Measured: after 3 months of Atorvastatin or placebo treatment.
Evaluation of the insulin-resistance associated to OSAS.
Measured: after 3 months of Atorvastatin or placebo treatment.
Evaluation of the hypercholesterolemia associated to OSAS.
Measured: 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.
Measured: after 6 months of treatments
Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.
Measured: after 3 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Interim analysis performed without efficient results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, MD, PhD, Principal investigator, University Hospital of Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669695
- Sponsor's protocol ID
- 0721
- Other IDs
- 2007-005286-35
- Acronym
- StatinflaSAS
- Status last verified
- Sep 2013
- First submitted
- 21 Apr 2008
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16337480Jullian-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.
PubMed 26567858Joyeux-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.
PubMed 25221387
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin
- ClinicalTrials.gov ID
- NCT00669695
- Acronym / sponsor ID
- StatinflaSAS / 0721
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- statins, cardiovascular risk, Obstructive sleep apnea syndrome (OSAS) patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis performed without efficient results
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 30 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stat/CPAP | Placebo comparator | Drug: Atorvastatin treatment, Other: CPAP deviceAtorvastatin and CPAP treatments |
| Stat/sham CPAP | Placebo comparator | Drug: Atorvastatin treatment, Other: sham CPAP treatmentAtorvastatin and sham CPAP treatments |
| Placebo/CPAP | Sham comparator | Other: CPAP devicePlacebo and CPAP treatments |
| Placebo/sham CPAP | Active comparator | Other: sham CPAP treatmentPlacebo and sham CPAP treatments |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin treatmentAlso: statinAtorvastatin treatment: tablets of 40 mg Atorvastatin will be administered orally, respecting the dosage of 40 mg/day, for 6 months. | Drug | Stat/CPAP, Stat/sham CPAP |
| CPAP deviceAlso: positive air way pressureThis 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 | Placebo/CPAP, Stat/CPAP |
| sham CPAP treatmentAlso: sham CPAPThis device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months. | Other | Placebo/sham CPAP, Stat/sham CPAP |
Primary outcome
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.
5 secondary outcomes
Evaluation of the inflammation occurring during OSAS.
Time frame: 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.
Evaluation of the hypercholesterolemia associated to OSAS.
Time frame: 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
Measurement of the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo.
Time frame: after 3 months of treatment.
Results and safety
The study was stopped early (reason given: Interim analysis performed without efficient results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
- Background: PubMed 16337480Bergeron 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.
- Derived from this study: PubMed 26567858Jullian-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.
- Derived from this study: PubMed 25221387Joyeux-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis PEPIN, MD, PhD principal investigator
University Hospital of Grenoble, France
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin treatment and CPAP device in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Grenoble at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim analysis performed without efficient results). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00669695, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2013.