Obstructive Sleep Apnea Clinical Trial
Official title:
Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea: a Randomized Controlled Trial
Severe obstructive sleep apnea (OSA) is associated with increased cardiovascular morbidity
and mortality. Endothelial dysfunction, an early marker of vascular disease has been
demonstrated in OSA. Regular treatment of OSA by continuous positive airway pressure (CPAP)
improves endothelial function and is associated with a reduction in cardiovascular risk.
Approximately 40% of patients with OSA are intolerant or insufficiently adherent to CPAP.
Alternative treatments or adjuvants to the CPAP are needed.
The polyphenols have demonstrated their effectiveness in improving endothelial function in
patients with CV disease. No randomized controlled studies have evaluated the impact of PPR
on the endothelial dysfunction associated with OSAHS.
The endpoint is the change to one month of polyphenols treatment of the endothelial function
measured by the index of hyperemic reactivity.
The secondary endpoints are changes at one month of supplementation with polyphenols of
ambulatory blood pressure measurement in 24 hours (MAPA), micro-circulatory responsiveness,
the speed of the pulse wave and biological measurements (lipid profile, blood glucose,
fasting insulin, leptin, adiponectin, hs-CRP, 8-isoprostane levels and cellular origin of
microparticles).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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