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NCT00863135 Clinical Trial

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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00863135
Other study ID # FIS PI070219
Secondary ID
Status Completed
Phase N/A
First received March 16, 2009
Last updated February 7, 2017
Start date December 2008
Est. completion date July 2016

Study information
Verified date February 2017
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- excessive sleepiness

- professional drivers

- secondary arterial hypertension

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CPAP
continuous positive airways pressure
• 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

Locations
Country Name City State
Spain Corporacio Parc Tauli Sabadell Barcelona

Sponsors (2)
Lead Sponsor Collaborator
Corporacion Parc Tauli Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 24 hours blood pressure monitoring basal and after three months of CPAP treatment
Secondary oxidative stress and inflammatory mediators basal and after three months of CPAP treatment
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