- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00863135
Effect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
February 7, 2017 updated by: Jaume Almirall, Corporacion Parc Tauli
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Barcelona
-
Sabadell, Barcelona, Spain, 08208
- Corporacio Parc Tauli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15
Exclusion Criteria:
- excessive sleepiness
- professional drivers
- secondary arterial hypertension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continuous Positive Airway Pressure
nocturnal continuous positive airways pressure
|
continuous positive airways pressure
|
Other: Control
Waiting list,3 months without any change in their treatment, come into the CPAP procedure after that time
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
24 hours blood pressure monitoring
Time Frame: basal and after three months of CPAP treatment
|
basal and after three months of CPAP treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
oxidative stress and inflammatory mediators
Time Frame: basal and after three months of CPAP treatment
|
basal and after three months of CPAP treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jaume Almirall, Dr, Corporacio Parc Tauli
- Study Chair: Juan-Carlos Martinez-Ocaña, Dr, Corporacio Parc Tauli
- Study Chair: Antonio Ferrer, Dr, Corporacio Parc Tauli
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
March 16, 2009
First Submitted That Met QC Criteria
March 16, 2009
First Posted (Estimate)
March 17, 2009
Study Record Updates
Last Update Posted (Estimate)
February 9, 2017
Last Update Submitted That Met QC Criteria
February 7, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIS PI070219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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