Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

— PolySAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01977924
• Other study ID #: 2013-A00763-42
• Status: Not yet recruiting
• Phase: N/A
• First received: October 31, 2013
• Last updated: November 12, 2013
• Start date: November 2013

Study information

• Verified date: November 2013
• Source: University Hospital, Angers
• Contact: wojciech trzepizur, MD
• Phone: +33(0) 214353695
• Email: wotrzepizur[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Dietary Supplement:
• one month polyphenols supplementation (600mg)

• placebo (microcrystalline cellulose)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial function measured by the index of hyperemic reactivity		one month	No