Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea

Not Applicable

• Conditions: Obstructive Sleep Apnea
• Interventions: Dietary Supplement: one month polyphenols supplementation (600mg); Dietary Supplement: placebo (microcrystalline cellulose)

• Registration Number: NCT01977924
• Lead Sponsor: University Hospital, Angers

Brief 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).

Study Timeline

• Study First Submitted: 2013-10-31
• Status Verified: 2013-11
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-07
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-13
• Primary Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•

• apnea hypopnea index > 30
• accepting polyphenols supplementation
• Signed informed consent

Exclusion Criteria

• Epworth sleepiness scale > 16/24
• Severe cardiac and/or respiratory disease
• BMI>35 kg/m2
• Anemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
polyphenols	one month polyphenols supplementation (600mg)	600 mg polyphenols (grape extract)
Placebo	placebo (microcrystalline cellulose)	microcrystalline cellulose

Primary Outcome Measures

Name	Time	Method
endothelial function measured by the index of hyperemic reactivity	one month