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

NCT01791270 | Completed

• 1 other identifier: P09-CTS-4971
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Hypertension; β1 Subunit of Maxi-k+Channel; Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  3 months

Study Arms (2)

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

Interventions

Continuous positive airway pressure (CPAP) therapy DEVICE

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.

OSA patients before and after treatment, CPAP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group of OSA patients and a control group without OSA

You may qualify if:

• 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

You may not qualify if:

• Awaking hypoxemia (PO2 in arterial blood gas \<70 mmHg) or arterial saturation \<90% in digital pulse oximetry.

Sponsors & Collaborators

• Angeles Sanchez Armengol: lead
• Junta de Andalucia: collaborator

Related Publications (1)

• Caballero-Eraso C, Munoz-Hernandez R, Asensio Cruz MI, Moreno Luna R, Carmona Bernal C, Lopez-Campos JL, Stiefel P, Sanchez Armengol A. Relationship between the endothelial dysfunction and the expression of the beta1-subunit of BK channels in a non-hypertensive sleep apnea group. PLoS One. 2019 Jun 19;14(6):e0217138. doi: 10.1371/journal.pone.0217138. eCollection 2019.

  PMID: 31216297 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Periferical blood

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension

Interventions

Continuous Positive Airway Pressure; Therapeutics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Respiratory Therapy

Study Officials

• Angeles Sánchez Armengol, Md PhD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 13, 2013
• Study Start: February 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: June 21, 2013

Record last verified: 2013-06