Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
This study is currently recruiting participants.
Verified June 2011 by Corporacion Parc Tauli
Sponsor:
Corporacion Parc Tauli
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Jaume Almirall, Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT00863135
First received: March 16, 2009
Last updated: February 10, 2012
Last verified: June 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea Refractory Arterial Hypertension |
Device: CPAP Other: Waiting list |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Corporacion Parc Tauli:
Primary Outcome Measures:
- 24 hours blood pressure monitoring [ Time Frame: basal and after three months of CPAP treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- oxidative stress and inflammatory mediators [ Time Frame: basal and after three months of CPAP treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CPAP
nocturnal continuous positive airways pressure
|
Device: CPAP
continuous positive airways pressure
|
|
No Intervention: Control
Waiting list
|
Other: Waiting list
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15
Exclusion Criteria:
- excessive sleepiness
- professional drivers
- secondary arterial hypertension
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863135
Contacts
| Contact: Jaume Almirall, Dr. | 00 937231010 ext 25013 | jalmirall@tauli.cat |
Locations
| Spain | |
| Corporacio Parc Tauli | Recruiting |
| Sabadell, Barcelona, Spain, 08208 | |
| Contact: Jaume Almirall, Dr 00 937231010 ext 25013 jalmirall@tauli.cat | |
| Contact: Joan-Carles Martinez-Ocaña, Dr 00 937231010 ext 25013 jcmartinez@tauli.cat | |
| Principal Investigator: Jaume Almirall, Dr | |
| Sub-Investigator: Juan-Carlos Martinez-Ocaña, Dr | |
| Sub-Investigator: Laura Vigil, Dr | |
| Sub-Investigator: Maria-Pau Valenzuela, Dr | |
| Sub-Investigator: Antoni Ferrer, Dr | |
Sponsors and Collaborators
Corporacion Parc Tauli
Carlos III Health Institute
Investigators
| Principal Investigator: | Jaume Almirall, Dr | Corporació Parc Taulí |
| Study Chair: | Juan-Carlos Martinez-Ocaña, Dr | Corporació Parc Tauli |
| Study Chair: | Antonio Ferrer, Dr | Corporacio Parc Tauli |
More Information
No publications provided
| Responsible Party: | Jaume Almirall, Dr., Corporacion Parc Tauli |
| ClinicalTrials.gov Identifier: | NCT00863135 History of Changes |
| Other Study ID Numbers: | FIS PI070219 |
| Study First Received: | March 16, 2009 |
| Last Updated: | February 10, 2012 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by Corporacion Parc Tauli:
|
obstructive sleep apnea refractory arterial hypertension continuous positive airways pressure |
Additional relevant MeSH terms:
|
Apnea Hypertension Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Vascular Diseases Cardiovascular Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013