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

February 7, 2017 updated by: Jaume Almirall, Corporacion Parc Tauli

Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15

Exclusion Criteria:

  • excessive sleepiness
  • professional drivers
  • secondary arterial hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous Positive Airway Pressure
nocturnal continuous positive airways pressure
continuous positive airways pressure
Other: Control
Waiting list,3 months without any change in their treatment, come into the CPAP procedure after that time
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24 hours blood pressure monitoring
Time Frame: basal and after three months of CPAP treatment
basal and after three months of CPAP treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
oxidative stress and inflammatory mediators
Time Frame: basal and after three months of CPAP treatment
basal and after three months of CPAP treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jaume Almirall, Dr, Corporacio Parc Tauli
  • Study Chair: Juan-Carlos Martinez-Ocaña, Dr, Corporacio Parc Tauli
  • Study Chair: Antonio Ferrer, Dr, Corporacio Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (Estimate)

March 17, 2009

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Sleep Apnea

Clinical Trials on CPAP

3
Subscribe