Sleep Apnea Syndromesdépist-ByNCT03129984
Mandibular Movement Test as a Screening Tool for Polysomnography Candidates
An observational study of Sleep Apnea Syndromes, run by University Hospital, Montpellier.
Trial summary
The primary objective of this study is to determine the technical failure and inconclusive test rates when using the Brizzy device for mandibular movement tracking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Mandibular movement tracking
- Type of treatment
- Medical device
- How many people
- 4,231 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study is re-evaluating data provided by the Brizzy register in Belgium.
Who may be able to join
- Patient included in the Brizzy register
- Mandibular movement test prescribed by practitioner
- Patient performed a mandibular movement test (ambulatory setting) using a magnetic sensor (Brizzy, Nomics, Liege, Belgium)
Who cannot join
- none
About this study
Official title: A Mandibular Movement Test as a Screening Tool for Polysomnography Candidates Among Patients With Sleep Apnea: a Retrospective Feasibility Study
The primary objective of this study is to determine the technical failure and inconclusive test rates when using the Brizzy device for mandibular movement tracking.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Mandibular movement tracking
- Keywords
- mandibular movements
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular movement trackingDevice
Also called Brizzy (Nomics, Liege, Belgium)
Patients wore the Brizzy device while sleeping. Mandibular movements (A mid-sagittal mandibular movement magnetic sensor measured the distance in mm between two parallel, coupled, resonant circuits placed on the forehead and chin.) were tracked during sleep.
| Study group | Role | What they receive |
|---|---|---|
| The study population | The study population is comprised of all patients included in the Brizzy register, Belgium. Receives: Device: Mandibular movement tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
The exploitable data rate
The number of usable tests / the number of tests performed.
Measured: Day 0 (retrospective cross-sectional study)
Secondary outcomes (6)
Respiratory disturbance index based on mandibular movements
Respiratory disturbance index based on mandibular movements (Brizzy, Nomics, Liege, Belgium)
Measured: Day 0 (retrospective cross-sectional study)
Minimal estimated total sleep time
Minimal estimated total sleep time
Measured: Day 0 (retrospective cross-sectional study)
ODI
The oxygen desaturation index (ODI) from oximetry.
Measured: Day 0 (retrospective cross-sectional study)
Type of prescriber (qualitative)
Was the prescriber a (choose one from among the following):
- cardiologist,
- general practitioner
- otorhinolaryngologist
- pneumologist
- orthodontist
- other
Measured: Day 0 (retrospective cross-sectional study)
Identification of reasons why a given test was unusable
Measured: Day 0 (retrospective cross-sectional study)
age
age in years
Measured: Day 0 (retrospective cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
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 Sleep Apnea SyndromesStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- nomics s.a.
- Responsible party
- Sponsor
- Investigators
- Dany Jaffuel, MD, PhD, Study director, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129984
- Sponsor's protocol ID
- RECHMPL17_0148
- Acronym
- dépist-By
- Status last verified
- Apr 2017
- First submitted
- 21 Apr 2017
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rotty MC, Mallet JP, Borel JC, Suehs CM, Bourdin A, Molinari N, Jaffuel D. The feasibility of a mandibular movement test as a screening tool for polysomnography candidates. Eur Respir J. 2017 Nov 30;50(5):1701076. doi: 10.1183/13993003.01076-2017. Print 2017 Nov. No abstract available.
PubMed 29191954
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mandibular Movement Test as a Screening Tool for Polysomnography Candidates Among Patients With Sleep Apnea: a Retrospective Feasibility Study
- ClinicalTrials.gov ID
- NCT03129984
- Acronym / sponsor ID
- dépist-By / RECHMPL17_0148
- Conditions
- Sleep Apnea Syndromes
- Keywords
- mandibular movements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,231 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- nomics s.a.
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Apr 2017 (actual)
- 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 primary objective of this study is to determine the technical failure and inconclusive test rates when using the Brizzy device for mandibular movement tracking.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Device: Mandibular movement trackingThe study population is comprised of all patients included in the Brizzy register, Belgium. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study is re-evaluating data provided by the Brizzy register in Belgium.
Key inclusion criteria (3 listed)
- Patient included in the Brizzy register
- Mandibular movement test prescribed by practitioner
- Patient performed a mandibular movement test (ambulatory setting) using a magnetic sensor (Brizzy, Nomics, Liege, Belgium)
Key exclusion criteria (1 listed)
- none
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 movement trackingAlso: Brizzy (Nomics, Liege, Belgium)Patients wore the Brizzy device while sleeping. Mandibular movements (A mid-sagittal mandibular movement magnetic sensor measured the distance in mm between two parallel, coupled, resonant circuits placed on the forehead and chin.) were tracked during sleep. | Device | The study population |
Primary outcome
The exploitable data rate
Time frame: Day 0 (retrospective cross-sectional study)
The number of usable tests / the number of tests performed.
6 secondary outcomes
Respiratory disturbance index based on mandibular movements
Time frame: Day 0 (retrospective cross-sectional study)
Minimal estimated total sleep time
Time frame: Day 0 (retrospective cross-sectional study)
ODI
Time frame: Day 0 (retrospective cross-sectional study)
Type of prescriber (qualitative)
Time frame: Day 0 (retrospective cross-sectional study)
Identification of reasons why a given test was unusable
Time frame: Day 0 (retrospective cross-sectional study)
age
Time frame: Day 0 (retrospective cross-sectional study)
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 3 Aug 2017.
- Derived from this study: PubMed 29191954Rotty MC, Mallet JP, Borel JC, Suehs CM, Bourdin A, Molinari N, Jaffuel D. The feasibility of a mandibular movement test as a screening tool for polysomnography candidates. Eur Respir J. 2017 Nov 30;50(5):1701076. doi: 10.1183/13993003.01076-2017. Print 2017 Nov. No abstract available.
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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.
Dany Jaffuel, MD, PhD study director
University Hospitals of Montpellier
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes, run by University Hospital, Montpellier.
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 1 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 3 Aug 2017. 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. 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?
The exploitable data rate (time frame: Day 0 (retrospective cross-sectional study)). 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 NCT03129984, 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 3 Aug 2017.