Obstructive Sleep Apnea (OSA), Hypertension , β1 Subunit of Maxi-k+ Channel and Cardiovascular Risk (OSAS)

This study has been completed.
Sponsor:
Collaborator:
Beca de Excelencia de la CICE de la Junta de Andalucia y programa Operativo FEDER de Andalucia
Information provided by (Responsible Party):
Angeles Sanchez Armengol, Sociedad Española de Neumología yu Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT01791270
First received: February 12, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

To describe the relationship between OSA and clinical Hypertension (performing ABPM), endothelial dysfunction (performing flowmetry), and its relation at the basic research (determining the β1 subunit in Peripheral Leukocytes in peripheral blood). This relation between OSA and HTA has been evaluated in basal conditions and after modifying the pathophysiological role of OSA applying treatment with positive continues pressure (CPAP) during 3 months.


Condition Intervention
Obstructive Sleep Apnea
Device: Continuous positive airway pressure (CPAP) therapy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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

Periferical blood


Enrollment: 80
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Procedures:

  1. - Respiratory Polygraphy
  2. - Ambulatory Blood Pressure Monitoring
  3. - Endothelial dysfunction, by determining the hyperaemic response to ischemia using a Laser-Doppler flowmeter.
  4. - ß1en subunit expression in peripheral blood leukocytes.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Group of OSA patients and a control group without OSA

Criteria

Inclusion Criteria:

  • The control group was defined as "absence of OSA"(apnea-hypopnea index (AHI) in cardiorespiratory polygraphy <5).
  • The "OSA" group was defined as OSA symptoms + an AHI ≥ 15 in cardiorespiratory polygraphy

Exclusion criteria:

  • Awaking hypoxemia (PO2 in arterial blood gas <70 mmHg) or arterial saturation <90% in digital pulse oximetry.
  • Treated hypertensive patients who were not well controlled at the time of inclusion: change of HTA treatment in the previous 3 months.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01791270

Sponsors and Collaborators
Angeles Sanchez Armengol
Beca de Excelencia de la CICE de la Junta de Andalucia y programa Operativo FEDER de Andalucia
Investigators
Principal Investigator: Angeles Sánchez Armengol, Md PhD Hospitales Universitarios Virgen del Rocío
  More Information

No publications provided

Responsible Party: Angeles Sanchez Armengol, MD PhD, Sociedad Española de Neumología yu Cirugía Torácica
ClinicalTrials.gov Identifier: NCT01791270     History of Changes
Other Study ID Numbers: P09-CTS-4971
Study First Received: February 12, 2013
Last Updated: June 20, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
Obstructive Sleep Apnea
Hypertension
β1 Subunit of Maxi-k+Channel
Cardiovascular Risk

Additional relevant MeSH terms:
Apnea
Hypertension
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014