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. (see Contacts and Locations)
Verified November 2013 by Corporacion Parc Tauli
Sponsor:
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: November 18, 2013
Last verified: November 2013
  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
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: October 2014
Estimated Primary Completion Date: June 2014 (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

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
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, see Learn About Clinical Studies.

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: November 18, 2013
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 August 28, 2014