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

NCT00202527 | Unknown

• 1 other identifier: PI041110
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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..

Conditions

Sleep Apnea; Hypertension

Keywords

Sleep apnea; Hypertension; CPAP

Outcome Measures

Primary Outcomes (2)

• Effect of CPAP in 24 hours blood pressure monitoring

• effect of CPAP y quality of life and clinical aspects

Secondary Outcomes (1)

• effect of CPAP in biologic mediators

Interventions

Nasal continuos positive airway pressure DEVICE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (1)

Unit of Research. Hospital Txagorritxu

Vitoria-Gasteiz, ALAVA, 01009, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 21106625 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Hypertension

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• JOAQUIN DURAN-CANTOLLA, MD

  Sociedad Española de Cirugía Torácica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JOAQUIN DURAN-CANTOLLA, MD

CONTACT

34 945 007308; joaquin.duran@wanadoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Study Completion: September 1, 2005
• Last Updated: December 23, 2005

Record last verified: 2005-09

Locations

ES (1)