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Effect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863135
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Jaume Almirall, Corporacion Parc Tauli

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Refractory Arterial Hypertension Device: CPAP Device: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension
Study Start Date : December 2008
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Continuous Positive Airway Pressure
nocturnal continuous positive airways pressure
Device: CPAP
continuous positive airways pressure

Control
Waiting list,3 months without any change in their treatment, come into the CPAP procedure after that time
Device: Control
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 Measures :
  1. 24 hours blood pressure monitoring [ Time Frame: basal and after three months of CPAP treatment ]

Secondary Outcome Measures :
  1. oxidative stress and inflammatory mediators [ Time Frame: basal and after three months of CPAP treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863135


Locations
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Spain
Corporacio Parc Tauli
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Carlos III Health Institute
Investigators
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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
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Responsible Party: Jaume Almirall, Dr., Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT00863135    
Other Study ID Numbers: FIS PI070219
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jaume Almirall, Corporacion Parc Tauli:
obstructive sleep apnea
refractory arterial hypertension
continuous positive airways pressure
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases