Spanish Cohort for the Study of the Effect of CPAP in Hypertension (CEPECTA)

Study Overview
=================
Brief Summary
-----------------
AIMS:To know the effects of the treatment with nasal positive continuous airway pressure (CPAP) on systemic blood pressure and the expression of biological mediators, in systemic hypertension of recent diagnostic, whose have an apnea-hypopnea index > 15. METHODOLOGY: DESIGN: Prospective, multicenter, randomized study, of parallel groups and controlled with placebo, in patients diagnosed of systemic hypertension (SH) with an apnea-hypopnea index, by conventional polysomnography > 15. A total of 340 patients with recently diagnosed of SH and without any pharmacological treatment will be studied. All patients will be randomized to receive, alternatively, CPAP treatment with optimal pressure titled with a proved system, or Sham-CPAP for 12 weeks. MEASUREMENTS: A) Conventional polysomnography at baseline: B) Clinic: sleepiness (ATS, Basic Nordic Sleep Questionnaire and Epworth), quality of life (EuroQol); C) 24 hour blood pressure monitoring; D) Expression of biological mediators in blood: general determinations, endothelial, inflammatory, lipid, renin-angiotensin-aldosterone and adrenergic mediators. ANALYSIS. Baseline measurements of all the variables will be compared with the situation at six and twelve weeks. We will use the chi square test and the Fisher´s exact test (categorical variables), the t test for continous variables and repeated measures ANCOVA for the primary objective. The analyses will be done under the criterion of intention to treat and for protocol. The variables will be controlled by the compliance with the CPAP..

Official Title
-----------------
Efficacy of the Treatment With Nasal Positive Continuous Airway Pressure to Reduce the Arterial Blood Pressure in Patients With Apneas-Hypopneas During the Sleep and Systemic Hypertension

Conditions
-----------------
Sleep Apnea, Hypertension

Intervention / Treatment
-----------------
* Device: Nasal continuos positive airway pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, both sexes from 18 to 75 years old, with clinical suspected of OSAH defined by an apnea-hypopnea index > 15 and having a recent diagnosis of hypertension which have not received any pharmacological treatment for hypertension. Exclusion Criteria: Inclusion Criteria: Patients with clinical suspected of OSAH defined by an apnea-hypopnea index > 15 and having a recent diagnosis of hypertension which have not received any pharmacological treatment for hypertension. Exclusion Criteria: Severe excessive daytime sleepiness; professional drivers; pregnant women; alcohol consumption more than 100 gr. Ethanol per day; sedative medication; psychiatric illness; malignant or complicated hypertension; renal insufficiency; severe chronically ilness or malignant ilness; severe craniomandibular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Nasal continuos positive airway pressure|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of CPAP in 24 hours blood pressure monitoring |  |  | 
| effect of CPAP y quality of life and clinical aspects |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of CPAP in biologic mediators |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep apnea, Hypertension, CPAP