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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01977924
Acronym
PolySAS
Enrollment
40
Registered
2013-11-07
Start date
2013-11-30
Completion date
Unknown
Last updated
2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea, polyphenols, endothelial function

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).

Interventions

DIETARY_SUPPLEMENTone month polyphenols supplementation (600mg)

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
endothelial function measured by the index of hyperemic reactivityone month

Contacts

Primary Contactwojciech trzepizur, MD
wotrzepizur@chu-angers.fr+33(0) 214353695

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026