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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00863135
First Posted: March 17, 2009
Last Update Posted: February 9, 2017
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.
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Jaume Almirall, Corporacion Parc Tauli
  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 Device: Control

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jaume Almirall, Corporacion Parc Tauli:

Primary Outcome Measures:
  • 24 hours blood pressure monitoring [ Time Frame: basal and after three months of CPAP treatment ]

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

Enrollment: 68
Study Start Date: December 2008
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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
Spain
Corporacio Parc Tauli
Sabadell, Barcelona, Spain, 08208
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

Responsible Party: Jaume Almirall, Dr., Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT00863135     History of Changes
Other Study ID Numbers: FIS PI070219
First Submitted: March 16, 2009
First Posted: March 17, 2009
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:
Hypertension
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases