Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea (PolySAS)

University Hospital, Angers

Status: Unknown

Conditions: Obstructive Sleep Apnea

Treatments: Dietary Supplement: one month polyphenols supplementation (600mg); Dietary Supplement: placebo (microcrystalline cellulose)

Study type: Interventional

Funder types: Other

Identifiers

NCT01977924

2013-A00763-42

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

polyphenols

Experimental group

Description:

600 mg polyphenols (grape extract)

Treatment:

Dietary Supplement: one month polyphenols supplementation (600mg)

Placebo

Placebo Comparator group

Description:

microcrystalline cellulose

Treatment:

Dietary Supplement: placebo (microcrystalline cellulose)