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

NCT ID: NCT00202527

Last Updated: 2005-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-09-30

Brief Summary

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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

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Conditions

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Sleep Apnea Hypertension

Keywords

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Sleep apnea Hypertension CPAP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nasal continuos positive airway pressure

Intervention Type DEVICE

Eligibility Criteria

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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.


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role lead

Principal Investigators

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JOAQUIN DURAN-CANTOLLA, MD

Role: PRINCIPAL_INVESTIGATOR

Sociedad Española de Cirugía Torácica

Locations

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Unit of Research. Hospital Txagorritxu

Vitoria-Gasteiz, ALAVA, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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JOAQUIN DURAN-CANTOLLA, MD

Role: CONTACT

Phone: 34 945 007308

Email: [email protected]

Facility Contacts

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JOAQUIN DURAN-CANTOLLA, MD

Role: primary

References

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Duran-Cantolla J, Aizpuru F, Montserrat JM, Ballester E, Teran-Santos J, Aguirregomoscorta JI, Gonzalez M, Lloberes P, Masa JF, De La Pena M, Carrizo S, Mayos M, Barbe F; Spanish Sleep and Breathing Group. Continuous positive airway pressure as treatment for systemic hypertension in people with obstructive sleep apnoea: randomised controlled trial. BMJ. 2010 Nov 24;341:c5991. doi: 10.1136/bmj.c5991.

Reference Type DERIVED
PMID: 21106625 (View on PubMed)

Other Identifiers

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PI041110

Identifier Type: -

Identifier Source: org_study_id