NCT01977924

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

1.5 years

First QC Date

October 31, 2013

Last Update Submit

November 12, 2013

Conditions

Obstructive Sleep Apnea

Keywords

sleep apneapolyphenolsendothelial function

Outcome Measures

Primary Outcomes (1)

  • endothelial function measured by the index of hyperemic reactivity

    one month

Study Arms (2)

polyphenols

EXPERIMENTAL

600 mg polyphenols (grape extract)

Dietary Supplement: one month polyphenols supplementation (600mg)

Placebo

PLACEBO COMPARATOR

microcrystalline cellulose

Dietary Supplement: placebo (microcrystalline cellulose)

Interventions

one month polyphenols supplementation (600mg)DIETARY_SUPPLEMENT
polyphenols
placebo (microcrystalline cellulose)DIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • apnea hypopnea index \> 30
  • accepting polyphenols supplementation
  • Signed informed consent

You may not qualify if:

  • Epworth sleepiness scale \> 16/24
  • Severe cardiac and/or respiratory disease
  • BMI\>35 kg/m2
  • Anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29659956DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

wojciech trzepizur, MD

CONTACT

+33(0) 214353695wotrzepizur@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 7, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2015

Last Updated

November 13, 2013

Record last verified: 2013-11