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

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
one month polyphenols supplementation (600mg)
placebo (microcrystalline cellulose)
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sleep apnea, polyphenols, endothelial function

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    polyphenols

    Placebo

    Arm Description

    600 mg polyphenols (grape extract)

    microcrystalline cellulose

    Outcomes

    Primary Outcome Measures

    endothelial function measured by the index of hyperemic reactivity

    Secondary Outcome Measures

    Full Information

    First Posted
    October 31, 2013
    Last Updated
    November 12, 2013
    Sponsor
    University Hospital, Angers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01977924
    Brief Title
    Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea
    Acronym
    PolySAS
    Official Title
    Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    May 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea
    Keywords
    sleep apnea, polyphenols, endothelial function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    polyphenols
    Arm Type
    Experimental
    Arm Description
    600 mg polyphenols (grape extract)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    microcrystalline cellulose
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    one month polyphenols supplementation (600mg)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo (microcrystalline cellulose)
    Primary Outcome Measure Information:
    Title
    endothelial function measured by the index of hyperemic reactivity
    Time Frame
    one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    wojciech trzepizur, MD
    Phone
    +33(0) 214353695
    Email
    wotrzepizur@chu-angers.fr

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29659956
    Citation
    Trzepizur W, Bironneau V, Recoquillon S, Priou P, Meslier N, Hamel JF, Henni S, Darsonval A, Messaoudi K, Martinez MC, Andriantsitohaina R, Gagnadoux F. Polyphenols Have No Impact on Endothelial Function in Patients with Obstructive Sleep Apnea: A Randomized Controlled Trial. J Nutr. 2018 Apr 1;148(4):581-586. doi: 10.1093/jn/nxy005.
    Results Reference
    derived

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    Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea

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