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

Not Applicable

• Conditions: Sleep Apnea; Hypertension

• Registration Number: NCT00202527
• Lead Sponsor: Sociedad Española de Neumología y Cirugía Torácica

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..

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Status Verified: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-20
• Last Update Submitted: 2005-12-22
• Last Update Posted: 2005-12-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of CPAP in 24 hours blood pressure monitoring
effect of CPAP y quality of life and clinical aspects

Secondary Outcome Measures

Name	Time	Method
effect of CPAP in biologic mediators

Trial Locations

Locations (1)

Unit of Research. Hospital Txagorritxu; 🇪🇸 Vitoria, Alava, Spain