Obstructive Sleep Apnea SyndromePhase 3NCT00801671
Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension
A Phase 3 study testing cPAP in people with Obstructive Sleep Apnea Syndrome and Hypertension, run by Russian Cardiology Research and Production Center at 1 site in Russia.
Trial summary
The purpose of this study is to determine whether CPAP is effective in the treatment of systemic hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Hypertension
- What is being tested?
- cPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2008to Jun 2011
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male/female over than 18 years old
- patient with an obstructive sleep apnea (apnea-hypopnea index > or equal to 15)
- patient with weak or moderate hypertension (140 <= SBP < 180 mmHg and 90 <= DBP < 110 mmHg)
- negative pregnancy test
- ambulatory patient
- patient who have signed the informed consent form
Who cannot join
- pregnant or nursing woman
- woman who refuses to use contraceptive method
- acute hepatic failure, biliary cirrhosis, cholestasis
- clearance of Cockcroft < 30 ml/min/1.73m2
- kaliemia >= 5.5 mmol/l
- acute hypertension (SBP>= 180 mmHg and/or DBP >= 110 mmHg)
Show all 14Show fewer
- acute daytime sleepiness (Epworth rating scale > 15)
- patient with a profession that is inconsistent with the continuous positive airway pressure (CPAP) treatment
- known cardiovascular pathologies
- contraindication to CPAP
- allergy to valsartan and/or amlodipine
- patient treated with lithium
- patient on tutelle or curatelle
- patient kept in detention, major protected by the law, hospitalized person patient currently participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Independent Role of Continuous Positive Airway Pressure Therapy on Systemic Arterial Pressure in Patients With Sleep Apnea Syndrome and Arterial Hypertension
The purpose of this study is to determine whether CPAP is effective in the treatment of systemic hypertension.
Read the detailed description
It is now well known that cardiovascular risks are increased in patients with obstructive sleep apnea syndrome (OSAS). Also a link has already been demonstrated between OSAS and hypertension.
Nowadays, the most efficient treatment of the OSAS is the continuous Positive Airway Pressure (cPAP). Several studies have also shown that cPAP could reduce arterial blood pressure in OSAS patients. But level of blood pressure (BP), drug treatment were not equal between groups and it's difficult to single out independent role of cPAP.
Our study has the objective to compare the effects of cPAP on hypertension in OSAS patients. After 3-9 weeks of antihypertensive treatment (valsartan and amlodipine) those one who reached target level of BP will be randomized either in the group "treatment by cPAP" or in the group "treatment by cham-cPAP" for 3 weeks and then we'll perform cross-over.
- Conditions
- Obstructive Sleep Apnea Syndrome, Hypertension
- Being tested
- cPAP
- Keywords
- obstructive sleep apnea, obstructive sleep apnea syndrome, hypertension, systemic hypertension, ambulatory blood pressure monitoring
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cPAPProcedure or surgery
After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: cPAP |
| 2 | Sham comparator | Not described Receives: Procedure: cPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), before cPAP (3-9 weeks) and after 3 weeks of cPAP.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Cardiology Research and Production Center
- Sponsor type
- University, hospital or other
- Investigators
- Alexandr Yu Litvin, MD, Principal investigator, Russian Cardiology Research and Production Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801671
- Sponsor's protocol ID
- 1111
- Status last verified
- Jun 2011
- First submitted
- 19 Jun 2008
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Litvin AY, Sukmarova ZN, Elfimova EM, Aksenova AV, Galitsin PV, Rogoza AN, Chazova IE. Effects of CPAP on "vascular" risk factors in patients with obstructive sleep apnea and arterial hypertension. Vasc Health Risk Manag. 2013;9:229-35. doi: 10.2147/VHRM.S40231. Epub 2013 May 10.
PubMed 23690688
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Independent Role of Continuous Positive Airway Pressure Therapy on Systemic Arterial Pressure in Patients With Sleep Apnea Syndrome and Arterial Hypertension
- ClinicalTrials.gov ID
- NCT00801671
- Acronym / sponsor ID
- 1111
- Conditions
- Obstructive Sleep Apnea Syndrome, Hypertension
- Keywords
- obstructive sleep apnea, obstructive sleep apnea syndrome, hypertension, systemic hypertension, ambulatory blood pressure monitoring
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Russian Cardiology Research and Production CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Dec 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 purpose of this study is to determine whether CPAP is effective in the treatment of systemic hypertension.
Detailed description
It is now well known that cardiovascular risks are increased in patients with obstructive sleep apnea syndrome (OSAS). Also a link has already been demonstrated between OSAS and hypertension.
Nowadays, the most efficient treatment of the OSAS is the continuous Positive Airway Pressure (cPAP). Several studies have also shown that cPAP could reduce arterial blood pressure in OSAS patients. But level of blood pressure (BP), drug treatment were not equal between groups and it's difficult to single out independent role of cPAP.
Our study has the objective to compare the effects of cPAP on hypertension in OSAS patients. After 3-9 weeks of antihypertensive treatment (valsartan and amlodipine) those one who reached target level of BP will be randomized either in the group "treatment by cPAP" or in the group "treatment by cham-cPAP" for 3 weeks and then we'll perform cross-over.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: cPAP |
| 2 | Sham comparator | Procedure: cPAP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male/female over than 18 years old
- patient with an obstructive sleep apnea (apnea-hypopnea index > or equal to 15)
- patient with weak or moderate hypertension (140 <= SBP < 180 mmHg and 90 <= DBP < 110 mmHg)
- negative pregnancy test
- ambulatory patient
Key exclusion criteria (14 listed)
- pregnant or nursing woman
- woman who refuses to use contraceptive method
- acute hepatic failure, biliary cirrhosis, cholestasis
- clearance of Cockcroft < 30 ml/min/1.73m2
- kaliemia >= 5.5 mmol/l
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 |
|---|---|---|
| cPAPAfter reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP) | Procedure or surgery | 1, 2 |
Primary outcome
Ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), before cPAP (3-9 weeks) and after 3 weeks of cPAP.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
- Derived from this study: PubMed 23690688Litvin AY, Sukmarova ZN, Elfimova EM, Aksenova AV, Galitsin PV, Rogoza AN, Chazova IE. Effects of CPAP on "vascular" risk factors in patients with obstructive sleep apnea and arterial hypertension. Vasc Health Risk Manag. 2013;9:229-35. doi: 10.2147/VHRM.S40231. Epub 2013 May 10.
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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.
Alexandr Yu Litvin, MD principal investigator
Russian Cardiology Research and Production Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cPAP in people with Obstructive Sleep Apnea Syndrome and Hypertension, run by Russian Cardiology Research and Production Center at 1 site in Russia.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), before cPAP (3-9 weeks) and after 3 weeks of cPAP. (time frame: 24 hours). 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 NCT00801671, which also lists 1 linked publication.
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 17 Jun 2011.