Obstructive Sleep Apnea (OSA), Hypertension , β1 Subunit of Maxi-k+ Channel and Cardiovascular Risk (OSAS)
|ClinicalTrials.gov Identifier: NCT01791270|
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : June 21, 2013
|Condition or disease||Intervention/treatment|
|Obstructive Sleep Apnea||Device: Continuous positive airway pressure (CPAP) therapy|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Observational Model:||Case Control|
|Official Title:||Expression of Maxi-k+ Channel β1 Subunit in Peripheral Leukocytes, Blood Pressure Values and the Presence of Endothelial Dysfunction in Patients With Obstructive Sleep Apnea|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2012|
OSA versus Control subjects.
sleep apnea-hypopnea syndrome and control
OSA patients before and after treatment, CPAP
Continuous positive pressure CPAP
Device: Continuous positive airway pressure (CPAP) therapy
Device: CPAP accordingly to the normal therapy in daily practice. In the group of 61 patients with OSA: we compared the results before and after three months of correct treatment with CPAP.
First, an automatic continuous positive airway pressure device (autoCPAP REMstar) was used to evaluate the pressure titration by night registration at patient home. AutoCPAP gets complete information about the optimum level to be set as therapeutic (CPAP pressure).
The patient has been reevaluated periodically in the outpatient Sleep Unit to verify proper adaptation and compliance of CPAP.
We considered a proper compliance when patients used CPAP ≥ 4 hours/day. This data has been extracted from the counter included in the CPAP compressor.
- Improvement in blood pressure parameters, in vascular endothelial function and in levels of β1 subunit expression of Maxi-K + channel in patients with OSA after treatment with CPAP [ Time Frame: 3 months ]
Primary Outcome Measure: Look at the difference in OSA and control subjects between the parameters that measure blood pressure in AMBP, the reactive hyperemia test for ischemia flowmetry technique and the expression levels of ß1 subunit of the Maxi-K + channel in peripheral blood leukocytes.
In OSA group patients after three months of correct treatment with CPAP, the goal is to find:
- Improvement in blood pressure parameters (ambulatory blood pressure).
- Improved parameters expressing vascular endothelial function at subclinical level (recorded by laser-Doppler flowmetry).
- Improvement in levels of β1 subunit expression of Maxi-K + channel in peripheral blood leukocytes (basic).
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791270
|Principal Investigator:||Angeles Sánchez Armengol, Md PhD||Hospitales Universitarios Virgen del Rocío|