Clinical Trials Directory

Trials / Completed

CompletedNCT00435643

Influence of nCPAP on Metabolic Consequences Associated With OSAS

Improvement in Hypothalamic-Pituitary-Adrenal Axis Function After Continuous Positive Airway Pressure Therapy in Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Federal University of São Paulo · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

Context: Obstructive sleep apnea syndrome (OSAS) is associated with cardiovascular morbidity. Recurrent episodes of occlusion of upper airways during sleep result in hormonal changes that may predispose to high cardiovascular risk.These risks can rapidly be reduced by effective nasal continuous positive airway pressure (nCPAP) therapy Objective: To evaluate hypothalamic pituitary adrenal axis, insulin resistance, blood pressure values and adipokines in severe obese patients with and without OSAS and to determine if continuous positive airway pressure therapy (nCPAP) influenced responses.

Detailed description

Background: There is evidence that obstructive sleep apnea syndrome (OSAS) increases the risk of cardiovascular events. Sympathetic nervous system and hypothalamic-pituitary-adrenal (HPA) axis activation may be the mechanism of this relationship. We evaluate HPA axis and metabolic consequences in obese patients with and without OSAS and we determine if continuous positive airway pressure therapy (nCPAP) influenced responses. Methods: Plasma inflammatory cytokines, insulin resistance index, 24-hour ambulatory blood pressure monitoring and overnight cortisol suppression test with 0.25 mg of dexamethasone were performed in 22 severe obese patients with OSAS and 23 obese controls. Ten patients with severe apnea were re-evaluated three months after nCPAP therapy. Results: Body mass index, abdominal circumference, blood pressure levels and insulin resistance indexes of OSAS patients and obese controls were very similar. In OSAS patients, adiponectin (p\<0.05) and salivary cortisol suppression pos DEX (p\<0.05) were lower, while heart rate (p\<0.05) and TNF-alpha levels (p\<0.05) were higher compared with obese controls. After nCPAP therapy, patients showed a reduction in heart rate (p=0.036) and a higher cortisol suppression after dexamethasone (p=0.001) and there were no differences in insulin resistance (HOMA p=0.139), arterial blood pressure (p=0.183) and adipokines compared with baseline. Cortisol suppression was positively correlated with the improvement of apnea hypopnea index while on nCPAP therapy (r= 0.799, p=0.010). Conclusions: Patients with OSAS present nocturnal hypercortisolism, hyperactivity of sympathetic central nervous system, a higher degree of inflammation and hypoadiponectinemia independent of the body mass index. Furthermore, hyperactivity of HPA axis and sympathetic nervous system are recovered by nCPAP.

Conditions

Interventions

TypeNameDescription
PROCEDUREnasal continuous positive airway pressureAfter an average interval of three months, 10 patients with severe OSAS (AHI of more than 30 events per hour of sleep) treated with a mean nCPAP pressure of 11.2 ± 0.7 cm of H2O were reassessed and all mentioned measurements above were repeated

Timeline

Start date
2004-10-01
Completion
2006-03-01
First posted
2007-02-15
Last updated
2007-11-20

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT00435643. Inclusion in this directory is not an endorsement.