Obstructive Sleep ApneaEpisasNCT03632382
Non-invasive Device for the Screening and Diagnosis of Sleep Apnea Syndrome
A study testing 3D acquisition of maxillofacial characteristics in people with Obstructive Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This prospective study aims to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- 3D acquisition of maxillofacial characteristics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2018to 8 Sep 2020
- 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 40 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI < 35 kg/m²
- caucasian men
- patients from the sleep laboratory (CHU Grenoble Alpes) admitted for a polysomnography
- Patient who has given free and informed consent in writing
Who cannot join
- history of maxillofacial surgery
- dental malocclusion
- patient involved in another clinical research study
- patient not affiliated with social security
- patient deprived of liberty or hospitalized without consent
Trial locations and contacts
1 site in 1 country.
About this study
This prospective study aims to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition.
Read the detailed description
Polysomnography is the gold-standard for obstructive sleep apnea (OSA) diagnosis. However, OSA is still undiagnosed. Maxillofacial profile can influence OSA severity. Morphological characteristics can be identified but are not enough measurable and analysable by physicians. 3D acquisition of maxillofacial characteristics with a user-friendly tool, quick and low-priced could be used to obtain a predictive model as an OSA risk indicator. Thus, the aim of this study is to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- 3D acquisition of maxillofacial characteristics
- Keywords
- Sleep apnea diagnosis, 3D acquisition
- 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.
3D acquisition of maxillofacial characteristicsDiagnostic test
A 3D acquisition of maxillofacial characteristics will be performed for each patient in order to validate a predictive model comparable to data obtained by polysomnography
| Study group | Role | What they receive |
|---|---|---|
| OSA diagnosis with 3D acquisition | Other | OSA diagnosis with 3D acquisition Receives: Diagnostic Test: 3D acquisition of maxillofacial characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish and evaluate a predictive model for OSA diagnosis by 3D acquisition of characteristics maxillofacial
apnea hypopnea index will be measured by polysomnography for each patient and compared to a predictive model establish from body mass index and 3D acquisition (cricomental distance...)
Measured: 1 measure at inclusion
Secondary outcomes (3)
Sensitivity study from different stages of OSA severity
OSA severity stages will be apnea hypopnea index <5, <10, <15
Measured: 1 measure at inclusion
Compare diagnosis performances of predictive model and Berlin or NoSAS questionnaires
Correlation between the Berlin or NoSAS score and the predictive model results
Measured: 1 measure at inclusion
Evaluate performances of the combination (Berlin questionnaire + predictive model) to estimate the OSA risk
Calculate the sensitivity, specificity, predictive positive value and predictive negative value of the combination
Measured: 1 measure at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start27 Jul 2018
- Primary completion27 Jul 2018
- Study completion8 Sep 2020
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, GrenobleThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- SATT Linksium GRENOBLE, ARTEHIS, ARCTIC
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632382
- Sponsor's protocol ID
- 38RC17.359
- Acronym
- Episas
- Status last verified
- Feb 2021
- First submitted
- 13 Aug 2018
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monna F, Ben Messaoud R, Navarro N, Baillieul S, Sanchez L, Loiodice C, Tamisier R, Joyeux-Faure M, Pepin JL. Machine learning and geometric morphometrics to predict obstructive sleep apnea from 3D craniofacial scans. Sleep Med. 2022 Jul;95:76-83. doi: 10.1016/j.sleep.2022.04.019. Epub 2022 Apr 29.
PubMed 35567881
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Device for the Screening and Diagnosis of Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT03632382
- Acronym / sponsor ID
- Episas / 38RC17.359
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep apnea diagnosis, 3D acquisition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- SATT Linksium GRENOBLE, ARTEHIS, ARCTIC
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 8 Sep 2020 (actual)
- First posted
- 15 Aug 2018 (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.
This prospective study aims to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition.
Detailed description
Polysomnography is the gold-standard for obstructive sleep apnea (OSA) diagnosis. However, OSA is still undiagnosed. Maxillofacial profile can influence OSA severity. Morphological characteristics can be identified but are not enough measurable and analysable by physicians. 3D acquisition of maxillofacial characteristics with a user-friendly tool, quick and low-priced could be used to obtain a predictive model as an OSA risk indicator. Thus, the aim of this study is to establish and evaluate a predictive model to diagnose OSA with maxillofacial characteristics 3D acquisition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective
| Arm | Type | Receives |
|---|---|---|
| OSA diagnosis with 3D acquisition | Other | Diagnostic Test: 3D acquisition of maxillofacial characteristicsOSA diagnosis with 3D acquisition |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI < 35 kg/m²
- caucasian men
- patients from the sleep laboratory (CHU Grenoble Alpes) admitted for a polysomnography
- Patient who has given free and informed consent in writing
Key exclusion criteria (5 listed)
- history of maxillofacial surgery
- dental malocclusion
- patient involved in another clinical research study
- patient not affiliated with social security
- patient deprived of liberty or hospitalized without consent
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 |
|---|---|---|
| 3D acquisition of maxillofacial characteristicsA 3D acquisition of maxillofacial characteristics will be performed for each patient in order to validate a predictive model comparable to data obtained by polysomnography | Diagnostic test | OSA diagnosis with 3D acquisition |
Primary outcome
Establish and evaluate a predictive model for OSA diagnosis by 3D acquisition of characteristics maxillofacial
Time frame: 1 measure at inclusion
apnea hypopnea index will be measured by polysomnography for each patient and compared to a predictive model establish from body mass index and 3D acquisition (cricomental distance...)
3 secondary outcomes
Sensitivity study from different stages of OSA severity
Time frame: 1 measure at inclusion
Compare diagnosis performances of predictive model and Berlin or NoSAS questionnaires
Time frame: 1 measure at inclusion
Evaluate performances of the combination (Berlin questionnaire + predictive model) to estimate the OSA risk
Time frame: 1 measure at inclusion
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 10 Feb 2021.
- Derived from this study: PubMed 35567881Monna F, Ben Messaoud R, Navarro N, Baillieul S, Sanchez L, Loiodice C, Tamisier R, Joyeux-Faure M, Pepin JL. Machine learning and geometric morphometrics to predict obstructive sleep apnea from 3D craniofacial scans. Sleep Med. 2022 Jul;95:76-83. doi: 10.1016/j.sleep.2022.04.019. Epub 2022 Apr 29.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Jean-Louis PEPIN principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D acquisition of maxillofacial characteristics in people with Obstructive Sleep Apnea, run by University Hospital, Grenoble 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 4 inclusion and 5 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 10 Feb 2021. 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?
Establish and evaluate a predictive model for OSA diagnosis by 3D acquisition of characteristics maxillofacial (time frame: 1 measure at inclusion). 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 NCT03632382, 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 10 Feb 2021.