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 by Corporacion Parc Tauli, March 2009

First Received: March 16, 2009 No Changes Posted

Sponsors and Collaborators:	Corporacion Parc Tauli Carlos III Health Institute
Information provided by:	Corporacion Parc Tauli
ClinicalTrials.gov Identifier:	NCT00863135

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	Other: CPAP

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Sleep Apnea

U.S. FDA Resources

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 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CPAP: Experimental nocturnal continuous positive airways pressure	Other: CPAP continuous positive airways pressure

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, Barcelona
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
Sub-Investigator: Thaïs Lopez, 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:	Corporacio Parc Tauli ( Dr Jaume Almirall )
Study ID Numbers:	FIS PI070219
Study First Received:	March 16, 2009
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00863135 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by Corporacion Parc Tauli:

obstructive sleep apnea
refractory arterial hypertension
continuous positive airways pressure

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Apnea, Obstructive

Vascular Diseases
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Hypertension

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Apnea
Nervous System Diseases
Sleep Apnea, Obstructive
Respiration Disorders
Vascular Diseases
Dyssomnias

Sleep Disorders
Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009