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

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ClinicalTrials.gov Identifier: NCT00202527
Recruitment Status : Unknown
Verified September 2005 by Sociedad Española de Neumología y Cirugía Torácica.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : December 23, 2005
Sponsor:
Information provided by:
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..


Condition or disease Intervention/treatment Phase
Sleep Apnea Hypertension Device: Nasal continuos positive airway pressure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : January 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Effect of CPAP in 24 hours blood pressure monitoring
  2. effect of CPAP y quality of life and clinical aspects

Secondary Outcome Measures :
  1. effect of CPAP in biologic mediators


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202527


Contacts
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Contact: JOAQUIN DURAN-CANTOLLA, MD 34 945 007308 joaquin.duran@wanadoo.es

Locations
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Spain
Unit of Research. Hospital Txagorritxu Recruiting
Vitoria, Alava, Spain, 01009
Contact: JOAQUIN DURAN-CANTOLLA, MD    34 945 007308    joaquin.duran@wanadoo.es   
Principal Investigator: JOAQUIN DURAN-CANTOLLA, MD         
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
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Principal Investigator: JOAQUIN DURAN-CANTOLLA, MD Sociedad Española de Cirugía Torácica
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00202527    
Other Study ID Numbers: PI041110
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 23, 2005
Last Verified: September 2005
Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
Sleep apnea
Hypertension
CPAP
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases