Remotely Controlled Mandibular PositionerRCMPNCT03231254
Differences in Predicted Therapeutic Outcome of Oral Appliance Determined by RCMP in Quebec Versus Shenyang Patients With OSA.
An observational study of Remotely Controlled Mandibular Positioner, run by First Hospital of China Medical University at 2 sites in 2 countries.
Trial summary
Study Objective: To explore the differences in predicted therapeutic outcome of OA and optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP) with overnight PSG in Quebec versus Shenyang patients with OSA. Design: A prospective, inter-ethnic pilot study. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Remotely Controlled Mandibular Positioner
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2017to 29 Oct 2017
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Research participants will be respectively recruited from Sleep Centre of IOCPQ of Laval (Quebec, Canada) and CMU first affiliated hospital (Shenyang, China), which receives the majority of referrals from respirologists, psychiatrists, otolaryngologists and dentists practicing in Quebec and Shenyang City. Consecutive patients between 20 and 75 years of age, satisfying the pre-mentioned inclusion will be considered eligible to our study.
Who may be able to join
- Recent diagnosis of OSAS (AHI>15/h) announced by a sleep recording; mean oxygen saturation >90%; mandibular range of motion >5 mm; adequate dentition: ≥10 upper and 10 lower teeth.
Who cannot join
- (1). Body mass index 40 kg/m2 or greater; (2).Inability to tolerate overnight polysomnography in sleep lab; (3).>50% of observed sleep apneas being central; (4). Other sleep disorders such as insomnia, narcolepsy, chronic sleep deficiency, periodic limb movement disorder or restless legs syndrome; (5). Those with severe pharyngeal obstruction on physical exam (pharyngeal grade more than II); (6).severe nasal obstruction.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Differences in Predicted Therapeutic Outcome of Oral Appliance and Optimal Protrusion Position Determined by Remotely Controlled Mandibular Positioner (RCMP) With Overnight PSG in Quebec Versus Shenyang Patients With OSA
Study Objective: To explore the differences in predicted therapeutic outcome of OA and optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP) with overnight PSG in Quebec versus Shenyang patients with OSA.
Design: A prospective, inter-ethnic pilot study. Setting: Two Standard sleep disorder clinical care in Quebec (Canada) and Shenyang (China), with oral appliance titration tests performed in sleep laboratory.
Read more
Participants: Consecutive specific OSA patients, who are potential candidates for treatment of OSA with an oral appliance (n=100, 50 Canadian, 50 Chinese), will be recruited from a sleep center or respirologists, psychiatrists, otolaryngologist and dentists practicing with broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI<40 kg/m2).
Interventions: A mandibular protrusive titration study in the PSG lab using a RCMP not only predicts the eventual therapeutic outcome but also prospectively determines Optimal Protrusive Position (OPP) for participants predicted to be therapeutically successful with OA therapy. One goal of this study is to identify OA favorable candidates by physicians using prospectively and explicitly designed criteria. Analyses of the predicted therapeutic outcome of OA and OPP between the two ethnic populations (patients in Quebec and Shenyang) will be processed after matching for OSA severity.
- Being tested
- Remotely Controlled Mandibular Positioner (RCMP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remotely Controlled Mandibular Positioner (RCMP)Device
RCMP device can accurately identify patients who are likely to be successful OA candidates. With a temporary dental appliance connected to a RCMP, the mandible could be progressively, mildly and precisely protruded in only anterior-posterior dimension, under the monitor of PSG, without disturbing sleep, until obstructive apneas and hypopneas were eliminated, particularly in REM sleep while supine. Besides, RCMP device can also determine the optimal therapeutic level of mandibular protrusion during sleep.
| Study group | Role | What they receive |
|---|---|---|
| Chinese patients with OSA | Not described Receives: Device: Remotely Controlled Mandibular Positioner (RCMP) | |
| Canada patients with OSA | Not described Receives: Device: Remotely Controlled Mandibular Positioner (RCMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences of predicted therapeutic outcome of OA between two groups.
To identify and compare the number of OA favorable candidates by physicians using prospectively and explicitly designed criteria in both groups.
Measured: 2017.7-2017.11
Secondary outcomes (1)
The differences of optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP) with overnight PSG in Quebec versus Shenyang patients with OSA.
Measured: 2017.7-2017.11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start1 Jul 2017
- Primary completion20 Oct 2017 (estimated)
- Study completion29 Oct 2017 (estimated)
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 Remotely Controlled Mandibular PositionerStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University
- Responsible party
- Principal investigator, Wenyang Li, First Hospital of China Medical University
- Investigators
- Wei Wang, PhD, Principal investigator, First Hospital of China Medical UniversityFrederic Series, master, Study director, Pneumologue Institut Universitaire de Cardiologie et de Pneumologie de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231254
- Sponsor's protocol ID
- AF-SOP-07-1.0-01
- Acronym
- RCMP
- Status last verified
- Jul 2017
- First submitted
- 25 Jul 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Remmers J, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, Bruehlmann S. Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. Sleep. 2013 Oct 1;36(10):1517-25, 1525A. doi: 10.5665/sleep.3048.
PubMed 24082311Li WY, Masse JF, Gakwaya S, Zhao Z, Wang W, Series F. Differences in Predicted Therapeutic Outcome of Mandibular Advancement Determined by Remotely Controlled Mandibular Positioner in Canadian and Chinese Apneic Patients. Nat Sci Sleep. 2022 Sep 8;14:1611-1622. doi: 10.2147/NSS.S377758. eCollection 2022.
PubMed 36105925
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Predicted Therapeutic Outcome of Oral Appliance and Optimal Protrusion Position Determined by Remotely Controlled Mandibular Positioner (RCMP) With Overnight PSG in Quebec Versus Shenyang Patients With OSA
- ClinicalTrials.gov ID
- NCT03231254
- Acronym / sponsor ID
- RCMP / AF-SOP-07-1.0-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Collaborators
- Laval University
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 20 Oct 2017 (estimated)
- Study completion
- 29 Oct 2017 (estimated)
- First posted
- 27 Jul 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.
Study Objective: To explore the differences in predicted therapeutic outcome of OA and optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP) with overnight PSG in Quebec versus Shenyang patients with OSA.
Design: A prospective, inter-ethnic pilot study. Setting: Two Standard sleep disorder clinical care in Quebec (Canada) and Shenyang (China), with oral appliance titration tests performed in sleep laboratory.
Participants: Consecutive specific OSA patients, who are potential candidates for treatment of OSA with an oral appliance (n=100, 50 Canadian, 50 Chinese), will be recruited from a sleep center or respirologists, psychiatrists, otolaryngologist and dentists practicing with broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI<40 kg/m2).
Interventions: A mandibular protrusive titration study in the PSG lab using a RCMP not only predicts the eventual therapeutic outcome but also prospectively determines Optimal Protrusive Position (OPP) for participants predicted to be therapeutically successful with OA therapy. One goal of this study is to identify OA favorable candidates by physicians using prospectively and explicitly designed criteria. Analyses of the predicted therapeutic outcome of OA and OPP between the two ethnic populations (patients in Quebec and Shenyang) will be processed after matching for OSA severity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese patients with OSA | – | Device: Remotely Controlled Mandibular Positioner (RCMP) |
| Canada patients with OSA | – | Device: Remotely Controlled Mandibular Positioner (RCMP) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Research participants will be respectively recruited from Sleep Centre of IOCPQ of Laval (Quebec, Canada) and CMU first affiliated hospital (Shenyang, China), which receives the majority of referrals from respirologists, psychiatrists, otolaryngologists and dentists practicing in Quebec and Shenyang City. Consecutive patients between 20 and 75 years of age, satisfying the pre-mentioned inclusion will be considered eligible to our study.
Key inclusion criteria (1 listed)
- Recent diagnosis of OSAS (AHI>15/h) announced by a sleep recording; mean oxygen saturation >90%; mandibular range of motion >5 mm; adequate dentition: ≥10 upper and 10 lower teeth.
Key exclusion criteria (1 listed)
- (1). Body mass index 40 kg/m2 or greater; (2).Inability to tolerate overnight polysomnography in sleep lab; (3).>50% of observed sleep apneas being central; (4). Other sleep disorders such as insomnia, narcolepsy, chronic sleep deficiency, periodic limb movement disorder or restless legs syndrome; (5). Those with severe pharyngeal obstruction on physical exam (pharyngeal grade more than II); (6).severe nasal obstruction.
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 |
|---|---|---|
| Remotely Controlled Mandibular Positioner (RCMP)RCMP device can accurately identify patients who are likely to be successful OA candidates. With a temporary dental appliance connected to a RCMP, the mandible could be progressively, mildly and precisely protruded in only anterior-posterior dimension, under the monitor of PSG, without disturbing sleep, until obstructive apneas and hypopneas were eliminated, particularly in REM sleep while supine. Besides, RCMP device can also determine the optimal therapeutic level of mandibular protrusion during sleep. | Device | Canada patients with OSA, Chinese patients with OSA |
Primary outcome
The differences of predicted therapeutic outcome of OA between two groups.
Time frame: 2017.7-2017.11
To identify and compare the number of OA favorable candidates by physicians using prospectively and explicitly designed criteria in both groups.
1 secondary outcome
The differences of optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP) with overnight PSG in Quebec versus Shenyang patients with OSA.
Time frame: 2017.7-2017.11
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Results publication: PubMed 24082311Remmers J, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, Bruehlmann S. Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. Sleep. 2013 Oct 1;36(10):1517-25, 1525A. doi: 10.5665/sleep.3048.
- Derived from this study: PubMed 36105925Li WY, Masse JF, Gakwaya S, Zhao Z, Wang W, Series F. Differences in Predicted Therapeutic Outcome of Mandibular Advancement Determined by Remotely Controlled Mandibular Positioner in Canadian and Chinese Apneic Patients. Nat Sci Sleep. 2022 Sep 8;14:1611-1622. doi: 10.2147/NSS.S377758. eCollection 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Remotely Controlled Mandibular Positioner
Recruiting
Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA
Obstructive Sleep Apnea, Maxillomandibular Advancement Surgery
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.
Wei Wang, PhD principal investigator
First Hospital of China Medical University
Frederic Series, master study director
Pneumologue Institut Universitaire de Cardiologie et de Pneumologie de Québec
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Remotely Controlled Mandibular Positioner, run by First Hospital of China Medical University at 2 sites in 2 countries.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, China. 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?
Results are not available in the source record.
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 differences of predicted therapeutic outcome of OA between two groups. (time frame: 2017.7-2017.11). 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 NCT03231254, 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 27 Jul 2017.