NCT01977924

Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea

Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	one month polyphenols supplementation (600mg)
DIETARY_SUPPLEMENT	placebo (microcrystalline cellulose)

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-05-01
• First posted: 2013-11-07
• Last updated: 2013-11-13