Back to resultsEffect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
Primary Purpose
Obstructive Sleep Apnea, Refractory Arterial Hypertension
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CPAP
Control
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, refractory arterial hypertension, continuous positive airways pressure
Eligibility Criteria
Inclusion Criteria:
- refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15
Exclusion Criteria:
- excessive sleepiness
- professional drivers
- secondary arterial hypertension
Sites / Locations
- Corporacio Parc Tauli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Continuous Positive Airway Pressure
Control
Arm Description
nocturnal continuous positive airways pressure
Waiting list,3 months without any change in their treatment, come into the CPAP procedure after that time
Outcomes
Primary Outcome Measures
24 hours blood pressure monitoring
Secondary Outcome Measures
oxidative stress and inflammatory mediators
Full Information
NCT ID
NCT00863135
First Posted
March 16, 2009
Last Updated
February 7, 2017
Sponsor
Corporacion Parc Tauli
Collaborators
Carlos III Health Institute
1. Study Identification
Unique Protocol Identification Number
NCT00863135
Brief Title
Effect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
Official Title
Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
Collaborators
Carlos III Health Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Refractory Arterial Hypertension
Keywords
obstructive sleep apnea, refractory arterial hypertension, continuous positive airways pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Positive Airway Pressure
Arm Type
Experimental
Arm Description
nocturnal continuous positive airways pressure
Arm Title
Control
Arm Type
Other
Arm Description
Waiting list,3 months without any change in their treatment, come into the CPAP procedure after that time
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
continuous positive airways pressure
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
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
Primary Outcome Measure Information:
Title
24 hours blood pressure monitoring
Time Frame
basal and after three months of CPAP treatment
Secondary Outcome Measure Information:
Title
oxidative stress and inflammatory mediators
Time Frame
basal and after three months of CPAP treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15
Exclusion Criteria:
excessive sleepiness
professional drivers
secondary arterial hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaume Almirall, Dr
Organizational Affiliation
Corporació Parc Taulí
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan-Carlos Martinez-Ocaña, Dr
Organizational Affiliation
Corporació Parc Tauli
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antonio Ferrer, Dr
Organizational Affiliation
Corporacio Parc Tauli
Official's Role
Study Chair
Facility Information:
Facility Name
Corporacio Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
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