Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202527
Status:
UNKNOWN
Last Update Posted:
2005-12-23
First Post:
2005-09-12
Brief Title:
Spanish Cohort for the Study of the Effect of CPAP in Hypertension CEPECTA
Sponsor:
Sociedad Española de Neumología y Cirugía Torácica
Organization:
Sociedad Española de Neumología y Cirugía Torácica
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
AIMSTo 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 Fishers 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
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 Fishers 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None