Obstructive Sleep Apnea SyndromeVASO-AMNCT01426607
VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
A study testing AMO in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Angers at 4 sites in France.
Trial summary
This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- AMO
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 4 sitesFrance
- Study dates
- Mar 2011to Mar 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
- AHI > 30
- Intolerance to CPAP therapy
- Signed informed consent
Who cannot join
- Epworth sleepiness scale > 16/24
- Severe cardiac and/or respiratory disease
- BMI>32 kg/m2
- Dental contraindication to oral appliance
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Grenoble
Grenoble, 38100
CH Le Mans
Le Mans, 72100
Hopital Saint Antoine
Paris, 75012
CHU Poitiers
Poitiers, 86000
About this study
This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- AMO
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMODevice
| Study group | Role | What they receive |
|---|---|---|
| AMO | Experimental | Adjustable mandibular repositioning appliance Receives: Device: AMO |
| placebo | Placebo comparator | placebo device in upper jaw Receives: Device: AMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function.
Measured: 2 months
Secondary outcomes (4)
change from baseline to 2-months in markers of OSA severity
Measured: 2 months
change from baseline to 2-months in blood pressure
Measured: 2 months
change from baseline to 2-months in symptoms of OSA
Measured: 2 months
evaluate treatment compliance objectively measured by an embedded micro sensor
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426607
- Sponsor's protocol ID
- PHRC 2010-06
- Acronym
- VASO-AM
- Status last verified
- Aug 2011
- First submitted
- 28 Jun 2011
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Recoquillon S, Pepin JL, Vielle B, Andriantsitohaina R, Bironneau V, Chouet-Girard F, Fleury B, Goupil F, Launois S, Martinez MC, Meslier N, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Gagnadoux F. Effect of mandibular advancement therapy on inflammatory and metabolic biomarkers in patients with severe obstructive sleep apnoea: a randomised controlled trial. Thorax. 2019 May;74(5):496-499. doi: 10.1136/thoraxjnl-2018-212609. Epub 2018 Oct 26.
PubMed 30366971Gagnadoux F, Pepin JL, Vielle B, Bironneau V, Chouet-Girard F, Launois S, Meslier N, Meurice JC, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Goupil F, Fleury B. Impact of Mandibular Advancement Therapy on Endothelial Function in Severe Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2017 May 1;195(9):1244-1252. doi: 10.1164/rccm.201609-1817OC.
PubMed 28128967
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01426607
- Acronym / sponsor ID
- VASO-AM / PHRC 2010-06
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Mar 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Aug 2011 (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.
This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMO | Experimental | Device: AMOAdjustable mandibular repositioning appliance |
| placebo | Placebo comparator | Device: AMOplacebo device in upper jaw |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AHI > 30
- Intolerance to CPAP therapy
- Signed informed consent
Key exclusion criteria (4 listed)
- Epworth sleepiness scale > 16/24
- Severe cardiac and/or respiratory disease
- BMI>32 kg/m2
- Dental contraindication to oral appliance
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 |
|---|---|---|
| AMO | Device | AMO, placebo |
Primary outcome
change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function.
Time frame: 2 months
4 secondary outcomes
change from baseline to 2-months in markers of OSA severity
Time frame: 2 months
change from baseline to 2-months in blood pressure
Time frame: 2 months
change from baseline to 2-months in symptoms of OSA
Time frame: 2 months
evaluate treatment compliance objectively measured by an embedded micro sensor
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Derived from this study: PubMed 30366971Recoquillon S, Pepin JL, Vielle B, Andriantsitohaina R, Bironneau V, Chouet-Girard F, Fleury B, Goupil F, Launois S, Martinez MC, Meslier N, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Gagnadoux F. Effect of mandibular advancement therapy on inflammatory and metabolic biomarkers in patients with severe obstructive sleep apnoea: a randomised controlled trial. Thorax. 2019 May;74(5):496-499. doi: 10.1136/thoraxjnl-2018-212609. Epub 2018 Oct 26.
- Derived from this study: PubMed 28128967Gagnadoux F, Pepin JL, Vielle B, Bironneau V, Chouet-Girard F, Launois S, Meslier N, Meurice JC, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Goupil F, Fleury B. Impact of Mandibular Advancement Therapy on Endothelial Function in Severe Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2017 May 1;195(9):1244-1252. doi: 10.1164/rccm.201609-1817OC.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMO in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Angers at 4 sites in France.
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: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function. (time frame: 2 months). 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 NCT01426607, which also lists 2 linked publications.
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 Dec 2016.