Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Dietary Supplement: one month polyphenols supplementation (600mg)
* Dietary Supplement: placebo (microcrystalline cellulose)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: polyphenols<br>600 mg polyphenols (grape extract) | Dietary Supplement: one month polyphenols supplementation (600mg)<br> <br> |
| Placebo Comparator: Placebo<br>microcrystalline cellulose | Dietary Supplement: placebo (microcrystalline cellulose)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function measured by the index of hyperemic reactivity |  | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, polyphenols, endothelial function