Obstructive Sleep ApneaNCT00863135
Effect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
A study testing CPAP in people with Obstructive Sleep Apnea and Refractory Arterial Hypertension, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The purpose of this study is to determine the effects of CPAP treatment on blood pressure in patients with sleep apnea syndrome (SAS) and refractory arterial hypertension (RAH). Also, some of the mechanisms mediating SAS and RAH (systemic inflammation, oxidative stress, sympathetic hyperactivity) will be analyzed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Refractory Arterial Hypertension
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2008to Jul 2016
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15
Who cannot join
- excessive sleepiness
- professional drivers
- secondary arterial hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
The purpose of this study is to determine the effects of CPAP treatment on blood pressure in patients with sleep apnea syndrome (SAS) and refractory arterial hypertension (RAH).
Also, some of the mechanisms mediating SAS and RAH (systemic inflammation, oxidative stress, sympathetic hyperactivity) will be analyzed.
- Being tested
- CPAP, Control
- Keywords
- obstructive sleep apnea, refractory arterial hypertension, continuous positive airways pressure
- 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.
CPAPDevice
continuous positive airways pressure
ControlDevice
Patients are 3 months without any change in their treatment, and are in the waiting list to come into the CPAP procedure after that time
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure | Experimental | nocturnal continuous positive airways pressure Receives: Device: CPAP |
| Control | Other | Waiting list,3 months without any change in their treatment, come into the CPAP procedure after that time Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours blood pressure monitoring
Measured: basal and after three months of CPAP treatment
Secondary outcomes (1)
oxidative stress and inflammatory mediators
Measured: basal and after three months of CPAP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Principal investigator, Jaume Almirall, Corporacion Parc Tauli
- Investigators
- Jaume Almirall, Dr, Principal investigator, Corporació Parc TaulíJuan-Carlos Martinez-Ocaña, Dr, Study chair, Corporació Parc TauliAntonio Ferrer, Dr, Study chair, Corporacio Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863135
- Sponsor's protocol ID
- FIS PI070219
- Status last verified
- Feb 2017
- First submitted
- 16 Mar 2009
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
- ClinicalTrials.gov ID
- NCT00863135
- Acronym / sponsor ID
- FIS PI070219
- Keywords
- obstructive sleep apnea, refractory arterial hypertension, continuous positive airways pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- Dec 2008
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Mar 2009 (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 the effects of CPAP treatment on blood pressure in patients with sleep apnea syndrome (SAS) and refractory arterial hypertension (RAH).
Also, some of the mechanisms mediating SAS and RAH (systemic inflammation, oxidative stress, sympathetic hyperactivity) will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure | Experimental | Device: CPAPnocturnal continuous positive airways pressure |
| Control | Other | Device: ControlWaiting list,3 months without any change in their treatment, come into the CPAP procedure after that time |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15
Key exclusion criteria (3 listed)
- excessive sleepiness
- professional drivers
- secondary arterial hypertension
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 |
|---|---|---|
| CPAPcontinuous positive airways pressure | Device | Continuous Positive Airway Pressure |
| ControlPatients are 3 months without any change in their treatment, and are in the waiting list to come into the CPAP procedure after that time | Device | Control |
Primary outcome
24 hours blood pressure monitoring
Time frame: basal and after three months of CPAP treatment
1 secondary outcome
oxidative stress and inflammatory mediators
Time frame: basal and after three months of CPAP treatment
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 9 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Jaume Almirall, Dr principal investigator
Corporació Parc Taulí
Juan-Carlos Martinez-Ocaña, Dr study chair
Corporació Parc Tauli
Antonio Ferrer, Dr study chair
Corporacio Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Obstructive Sleep Apnea and Refractory Arterial Hypertension, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 inclusion and 3 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 9 Feb 2017. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
24 hours blood pressure monitoring (time frame: basal and after three months of CPAP treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2017.