Syndrome of Obstructive Sleep Apnea and HypopneasNCT02878629
Mandibular Advancement Devices Tali® in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas
An observational study of Syndrome of Obstructive Sleep Apnea and Hypopneas, run by ONIRIS at 1 site in France.
Trial summary
The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Syndrome of Obstructive Sleep Apnea and Hypopneas
- What is being tested?
- Mandibular Advancement Devices
- Type of treatment
- Medical device
- How many people
- 254 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Aug 2019
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients > 18 years treated with Mandibular Advancement Device Tali® from at least 2 years and at the latest 5 years.
Who may be able to join
- Patients > 18 years treated with Mandibular Advancement Device Tali® from at least 2 years and at the latest 5 years.
- Patients who agree to participate to the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.
- Being tested
- Mandibular Advancement Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Advancement DevicesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance (no stop of the Mandibular Advancement Device)
Measured: 2 years or more after the beginning of device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndrome of Obstructive Sleep Apnea and HypopneasStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- ONIRIS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878629
- Sponsor's protocol ID
- OAM Tali®
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2016
- Last updated
- 28 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Advancement Devices Tali® in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas
- ClinicalTrials.gov ID
- NCT02878629
- Acronym / sponsor ID
- OAM Tali®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- ONIRISIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 25 Aug 2016 (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.
The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients > 18 years treated with Mandibular Advancement Device Tali® from at least 2 years and at the latest 5 years.
Key inclusion criteria (2 listed)
- Patients > 18 years treated with Mandibular Advancement Device Tali® from at least 2 years and at the latest 5 years.
- Patients who agree to participate to the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mandibular Advancement Devices | Device | – |
Primary outcome
compliance (no stop of the Mandibular Advancement Device)
Time frame: 2 years or more after the beginning of device
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 28 Aug 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syndrome of Obstructive Sleep Apnea and Hypopneas, run by ONIRIS at 1 site 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 2 inclusion and 0 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
compliance (no stop of the Mandibular Advancement Device) (time frame: 2 years or more after the beginning of device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2019.