Obstructive Sleep ApneaIRISNCT02348970
Efficacy and Compliance of the Mandibular Advancement Devices ONIRIS® vs. Custom Made Devices
A study testing ONIRIS® and TALI in people with Obstructive Sleep Apnea, run by ONIRIS at 10 sites in France.
Trial summary
To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use. Sleeping tests were performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- ONIRIS® and TALI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 10 sitesFrance
- Study dates
- Jan 2015to 28 Apr 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with severe syndrome of obstructive sleep apnea and hypopneas refusing or withdrawal from continuous positive pression ventilation
- no dental, paro-dental or articular contraindication
- patients never treated by mandibular advancement devices
Who cannot join
- severe psychiatric or neuromuscular disorders appreciated by the investigator
- more than 20% of apneas and central hypoapneas
- severe syndrome of obstructive sleep apnea and hypopneas with IAH > 30% associated with another sleeping pathology
- BMI > 30kg/m2
- patient with an uncontrollable nausea reflex
- epileptic patients
- pregnant patients
- patient without written informed consent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Clinique Bel-Air
Bordeaux
Polyclinique Saint Privat
Boujan-sur-Libron
CHU de Grenoble
La Tronche
Hôpital André Mignot
Le Chesnay, 78157
Medical Practice
Les Pavillons-sous-Bois, 93320
Medical Practice
Maisons-Alfort
CHU Montpellier
Montpellier
Fondation Ophtalmologique Adolphe de Rothschild
Paris
Medical Practice
Perpignan
Centre Cardiologique du Nord
Saint-Denis
About this study
Official title: Multicenters, Randomised Clinical Trial, to Evaluate Efficacy and Compliance of Mandibular Advancement Devices ONIRIS® vs. Laboratory Devices TALI in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas
To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use. Sleeping tests were performed.
Read the detailed description
Open, non-inferiority, controlled and rndomised clinical trial. Six months of inclusion. Each included patient will be followed during 12 months.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- ONIRIS®, TALI
- Keywords
- mandibular advancement devices ONIRIS®, obstructive sleep apnea and hypopneas
- 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.
ONIRIS®Device
sleeping test
TALIDevice
sleeping test
| Study group | Role | What they receive |
|---|---|---|
| mandibular advancement devices ONIRIS® | Experimental | The patients will use the mandibular advancement devices ONIRIS® Receives: Device: ONIRIS® |
| laboratory devices TALI | Active comparator | The patients will use the laboratory devices TALI Receives: Device: TALI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacity (non-inferiority) in terms of response between patients using mandibular advancement devices ONIRIS® and patient using devices produced in a laboratoryTALI after 2 months of use.
The response to the treatment is defined as:
- complete patient response: AHI per hour of sleep < 10 or
- partial patient response: AHI per hour of sleep reduced by 50% at visit M2 compared to baseline
Measured: 2 monthes of use
Secondary outcomes (8)
Evolution of AHI, AI and HI
AHI per hour of sleep with the same modalities as the one used for diagnosis (realised by ambulatory PG or PSG)
Measured: at M2 and at M12
Percentage of patients responder
Percentage of patients responder at the last control exam
Measured: at M2 and M12
Evolution during the study of the principal criteria concerning the sleep
Snoring measured by VAS, Epworth Sleepness Scale measuring daytime sleepness, Pichot Questionnaire measuring fatigue and depression
Measured: at baseline, M2, M6 and M12
Evolution of the quality of life
Quality of life evaluated by SF12 at each visit
Measured: at baseline, M2, M6 and M12
Evolution of the compliance
Percantage of compliance (excellent > 85%, good > 50%)
Measured: at M2, M6 and M12
Evolution of tolerance
Nature, frequency and intensity of AE at each visit
Measured: at M2, M6 and M12
AE and SAE occuring during the study
Description and comparison at each group of AE and SAE
Measured: at M2, M6 and M12
Evolution of arterial hypertension
Arterial hypertension evaluated at each visit
Measured: at baseline, M2, M6 and M12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion28 Apr 2018
- Study completion28 Apr 2018
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.
- 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
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- ONIRIS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- RAYMOND Nathalie, MD, Principal investigator, Hôpital Bel Air
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348970
- Sponsor's protocol ID
- ONI-003
- Acronym
- IRIS
- Status last verified
- Aug 2018
- First submitted
- 12 Jan 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pepin JL, Raymond N, Lacaze O, Aisenberg N, Forcioli J, Bonte E, Bourdin A, Launois S, Tamisier R, Molinari N. Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial. Thorax. 2019 Jul;74(7):667-674. doi: 10.1136/thoraxjnl-2018-212726. Epub 2019 May 3.
PubMed 31053619
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenters, Randomised Clinical Trial, to Evaluate Efficacy and Compliance of Mandibular Advancement Devices ONIRIS® vs. Laboratory Devices TALI in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas
- ClinicalTrials.gov ID
- NCT02348970
- Acronym / sponsor ID
- IRIS / ONI-003
- Conditions
- Obstructive Sleep Apnea
- Keywords
- mandibular advancement devices ONIRIS®, obstructive sleep apnea and hypopneas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- ONIRISIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- 28 Apr 2018 (actual)
- Study completion
- 28 Apr 2018 (actual)
- First posted
- 28 Jan 2015 (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.
To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use. Sleeping tests were performed.
Detailed description
Open, non-inferiority, controlled and rndomised clinical trial. Six months of inclusion. Each included patient will be followed during 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mandibular advancement devices ONIRIS® | Experimental | Device: ONIRIS®The patients will use the mandibular advancement devices ONIRIS® |
| laboratory devices TALI | Active comparator | Device: TALIThe patients will use the laboratory devices TALI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with severe syndrome of obstructive sleep apnea and hypopneas refusing or withdrawal from continuous positive pression ventilation
- no dental, paro-dental or articular contraindication
- patients never treated by mandibular advancement devices
Key exclusion criteria (8 listed)
- severe psychiatric or neuromuscular disorders appreciated by the investigator
- more than 20% of apneas and central hypoapneas
- severe syndrome of obstructive sleep apnea and hypopneas with IAH > 30% associated with another sleeping pathology
- BMI > 30kg/m2
- patient with an uncontrollable nausea reflex
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 |
|---|---|---|
| ONIRIS®sleeping test | Device | mandibular advancement devices ONIRIS® |
| TALIsleeping test | Device | laboratory devices TALI |
Primary outcome
To evaluate the efficacity (non-inferiority) in terms of response between patients using mandibular advancement devices ONIRIS® and patient using devices produced in a laboratoryTALI after 2 months of use.
Time frame: 2 monthes of use
The response to the treatment is defined as: * complete patient response: AHI per hour of sleep < 10 or * partial patient response: AHI per hour of sleep reduced by 50% at visit M2 compared to baseline
8 secondary outcomes
Evolution of AHI, AI and HI
Time frame: at M2 and at M12
Percentage of patients responder
Time frame: at M2 and M12
Evolution during the study of the principal criteria concerning the sleep
Time frame: at baseline, M2, M6 and M12
Evolution of the quality of life
Time frame: at baseline, M2, M6 and M12
Evolution of the compliance
Time frame: at M2, M6 and M12
Evolution of tolerance
Time frame: at M2, M6 and M12
AE and SAE occuring during the study
Time frame: at M2, M6 and M12
Evolution of arterial hypertension
Time frame: at baseline, M2, M6 and M12
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 31 Aug 2018.
- Derived from this study: PubMed 31053619Pepin JL, Raymond N, Lacaze O, Aisenberg N, Forcioli J, Bonte E, Bourdin A, Launois S, Tamisier R, Molinari N. Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial. Thorax. 2019 Jul;74(7):667-674. doi: 10.1136/thoraxjnl-2018-212726. Epub 2019 May 3.
- Individual participant dataSharing planned: No
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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.
RAYMOND Nathalie, MD principal investigator
Hôpital Bel Air
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONIRIS® and TALI in people with Obstructive Sleep Apnea, run by ONIRIS at 10 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 8 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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?
To evaluate the efficacity (non-inferiority) in terms of response between patients using mandibular advancement devices ONIRIS® and patient using devices produced in a laboratoryTALI after 2 months of use. (time frame: 2 monthes of use). 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 NCT02348970, 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 31 Aug 2018.