Obstructive Sleep ApneaPolySASNCT01977924
Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea
A study testing one month polyphenols supplementation (600mg) in people with Obstructive Sleep Apnea, run by University Hospital, Angers.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- one month polyphenols supplementation (600mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- apnea hypopnea index > 30
- accepting polyphenols supplementation
- Signed informed consent
Who cannot join
- Epworth sleepiness scale > 16/24
- Severe cardiac and/or respiratory disease
- BMI>35 kg/m2
- Anemia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea: a Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Obstructive Sleep Apnea
- Being tested
- one month polyphenols supplementation (600mg), placebo (microcrystalline cellulose)
- Keywords
- sleep apnea, polyphenols, endothelial function
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one month polyphenols supplementation (600mg)Dietary supplement
placebo (microcrystalline cellulose)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| polyphenols | Experimental | 600 mg polyphenols (grape extract) Receives: Dietary Supplement: one month polyphenols supplementation (600mg) |
| Placebo | Placebo comparator | microcrystalline cellulose Receives: Dietary Supplement: placebo (microcrystalline cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function measured by the index of hyperemic reactivity
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977924
- Sponsor's protocol ID
- 2013-A00763-42
- Acronym
- PolySAS
- Status last verified
- Nov 2013
- First submitted
- 31 Oct 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29659956
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01977924
- Acronym / sponsor ID
- PolySAS / 2013-A00763-42
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep apnea, polyphenols, endothelial function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Nov 2013
- Primary completion
- May 2015 (estimated)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyphenols | Experimental | Dietary Supplement: one month polyphenols supplementation (600mg)600 mg polyphenols (grape extract) |
| Placebo | Placebo comparator | Dietary Supplement: placebo (microcrystalline cellulose)microcrystalline cellulose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- apnea hypopnea index > 30
- accepting polyphenols supplementation
- Signed informed consent
Key exclusion criteria (4 listed)
- Epworth sleepiness scale > 16/24
- Severe cardiac and/or respiratory disease
- BMI>35 kg/m2
- Anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one month polyphenols supplementation (600mg) | Dietary supplement | polyphenols |
| placebo (microcrystalline cellulose) | Dietary supplement | Placebo |
Primary outcome
endothelial function measured by the index of hyperemic reactivity
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Derived from this study: PubMed 29659956Trzepizur 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing one month polyphenols supplementation (600mg) in people with Obstructive Sleep Apnea, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wojciech trzepizur, MD (+33(0) 214353695, wotrzepizur@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial function measured by the index of hyperemic reactivity (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01977924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013; AzTrials last refreshed its copy on 2 Nov 2026.