Obstructive Sleep ApneaNCT03929549
Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA
A study testing RCMP titration in people with Obstructive Sleep Apnea and Maxillomandibular Advancement Surgery, run by University of Michigan at 1 site in United States.
Trial summary
Maxillomandibular advancement (MMA) surgery, one of the most successful surgical procedures for the treatment of obstructive sleep apnea (OSA), is predominantly used to manage patients with moderate to severe OSA. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea, Maxillomandibular Advancement Surgery
- What is being tested?
- RCMP titration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2019to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI ≥ 15/hour
- 30-65 years of age
- BMI 25-34.9
- Ideal operative candidate
- Unable or unwilling to use PAP
Who cannot join
- BMI ≥ 35
- younger than 30 or older than 65 years of age
- pregnancy
- Central sleep apnea (CSA) on baseline polysomnogram
- Chronic opioid use
- Active TMJ Disorders
Show all 9Show fewer
- Inability to protrude the mandible beyond 5 mm
- Inability to follow-up after surgery
- Dental disorders including loose teeth or advanced periodontal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michigan Medicine Oral and Maxillofacial Surgery
Ann Arbor, Michigan, 48109
Jennifer a Lay-Luskin, MPhil, 734-936-5950, jalay@med.umich.edu
About this study
Official title: Preliminary Evaluation of a Remotely Controlled Mandibular Positioner to Predict Failure of Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea
Maxillomandibular advancement (MMA) surgery, one of the most successful surgical procedures for the treatment of obstructive sleep apnea (OSA), is predominantly used to manage patients with moderate to severe OSA. However, limiting factors include incomplete response in some cases, unfavorable facial changes as a result of large advancements, and risk of malocclusion or malunion.
This study will be done to determine predictors of success with MMA surgery in patients with moderate to severe OSA. Studies have already shown the value of a remote controlled mandibular positioner (RCMP) device to identify the correct level of therapeutic protrusion needed with oral appliance therapy. Moreover, some patients experience a dose dependent improvement in sleep parameters based on the degree of protrusion during the titration study. Use of RCMP as a means to identify potential candidates for MMA, may help customize treatment options for patients with OSA by providing predictive value.
Read the detailed description
The use of a remotely controlled mandibular protrusion (RCMP) device allows for customization of treatment by titrating the extent of mandibular protrusion during a polysomnogram. Use of the RCMP device has a high degree of positive and negative predictive value in determining the effectiveness and degree (effective target protrusive position) of mandibular advancement need with oral appliance therapy (Remmers, 2013). Preliminary data from 4 patients (Hoekena 2006) indicates that patients with a significant response to oral appliance therapy (>50% reduction in AHI) may have a better response to MMA. This study will determine the efficacy of MMA in patients with moderate to severe OSA, and determine if the RCMP titration can predict success or failure with MMA for treatment of OSA.
Patients will undergo detailed history and physical examination by Oral \& Maxillofacial Surgery. Those patients found to be potential candidates for jaw advancement (MMA) surgery will be recruited to enroll in the study. Once consented and enrolled, study participants will undergo a titration study using a remote controlled mandibular positioner (RCMP titration study) to evaluate changes in polysomnographic parameters (i.e. Apnea-hypopnea index and oxygen saturation) with mandibular protrusion. Patients will then undergo maxillomandibular advancement surgery (MMA surgery). During MMA surgery, a standard 10 mm advancement of the upper and lower jaw is performed. Slight modifications may be made to the degree of advancement in order to achieve acceptable facial esthetics. Data from the RCMP titration study will not affect how the MMA surgery is performed. After surgery, participants will have a follow-up polysomnogram four to eight months post-operatively to assess for treatment response and compared this to the predicted response based on the RCMP titration study.
- Being tested
- RCMP titration
- 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.
RCMP titrationDevice
Also called Remotely Controlled Mandibular Positioner
An overnight titration polysomnogram with gradual mandibular protrusion and assessment of polysomnographic parameters (i.e. AHI, oxygen saturation, etc.) at various magnitudes of protrusion.
| Study group | Role | What they receive |
|---|---|---|
| RCMP titration | Experimental | Remotely Controlled Mandibular Positioner Receives: Device: RCMP titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome variable: Change in AHI (pre-post) with MMA surgery
Secondary outcome variable: Failure of MMA surgery defined as AHI ≥ 15/hour
Measured: baseline (pre-operative), post surgery (6 months)
Primary predictor variable: Change in AHI, from baseline to maximal therapeutic protrusion, with RCMP study
age, sex, BMI, AHI, retrognathia, airway collapse on forced inspiration, AHI reduction on RCMP titration and magnitude of advancement.
Measured: baseline (pre-operative), post surgery (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start12 Aug 2019
- Primary completion31 Dec 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Aronovich, University of Michigan
- Investigators
- Sharon Aronovich, DMD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929549
- Sponsor's protocol ID
- HUM00143739
- Other IDs
- M-ROSA trial
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2019
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We will share deidentified individual patient data which supports the results reported in research publications. The data will be published as supplemental files with the original publication.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of a Remotely Controlled Mandibular Positioner to Predict Failure of Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03929549
- Acronym / sponsor ID
- HUM00143739
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 29 Apr 2019 (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.
Maxillomandibular advancement (MMA) surgery, one of the most successful surgical procedures for the treatment of obstructive sleep apnea (OSA), is predominantly used to manage patients with moderate to severe OSA. However, limiting factors include incomplete response in some cases, unfavorable facial changes as a result of large advancements, and risk of malocclusion or malunion.
This study will be done to determine predictors of success with MMA surgery in patients with moderate to severe OSA. Studies have already shown the value of a remote controlled mandibular positioner (RCMP) device to identify the correct level of therapeutic protrusion needed with oral appliance therapy. Moreover, some patients experience a dose dependent improvement in sleep parameters based on the degree of protrusion during the titration study. Use of RCMP as a means to identify potential candidates for MMA, may help customize treatment options for patients with OSA by providing predictive value.
Detailed description
The use of a remotely controlled mandibular protrusion (RCMP) device allows for customization of treatment by titrating the extent of mandibular protrusion during a polysomnogram. Use of the RCMP device has a high degree of positive and negative predictive value in determining the effectiveness and degree (effective target protrusive position) of mandibular advancement need with oral appliance therapy (Remmers, 2013). Preliminary data from 4 patients (Hoekena 2006) indicates that patients with a significant response to oral appliance therapy (>50% reduction in AHI) may have a better response to MMA. This study will determine the efficacy of MMA in patients with moderate to severe OSA, and determine if the RCMP titration can predict success or failure with MMA for treatment of OSA.
Patients will undergo detailed history and physical examination by Oral \& Maxillofacial Surgery. Those patients found to be potential candidates for jaw advancement (MMA) surgery will be recruited to enroll in the study. Once consented and enrolled, study participants will undergo a titration study using a remote controlled mandibular positioner (RCMP titration study) to evaluate changes in polysomnographic parameters (i.e. Apnea-hypopnea index and oxygen saturation) with mandibular protrusion. Patients will then undergo maxillomandibular advancement surgery (MMA surgery). During MMA surgery, a standard 10 mm advancement of the upper and lower jaw is performed. Slight modifications may be made to the degree of advancement in order to achieve acceptable facial esthetics. Data from the RCMP titration study will not affect how the MMA surgery is performed. After surgery, participants will have a follow-up polysomnogram four to eight months post-operatively to assess for treatment response and compared this to the predicted response based on the RCMP titration study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RCMP titration | Experimental | Device: RCMP titrationRemotely Controlled Mandibular Positioner |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AHI ≥ 15/hour
- 30-65 years of age
- BMI 25-34.9
- Ideal operative candidate
- Unable or unwilling to use PAP
Key exclusion criteria (9 listed)
- BMI ≥ 35
- younger than 30 or older than 65 years of age
- pregnancy
- Central sleep apnea (CSA) on baseline polysomnogram
- Chronic opioid use
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 |
|---|---|---|
| RCMP titrationAlso: Remotely Controlled Mandibular PositionerAn overnight titration polysomnogram with gradual mandibular protrusion and assessment of polysomnographic parameters (i.e. AHI, oxygen saturation, etc.) at various magnitudes of protrusion. | Device | RCMP titration |
Primary outcome
Primary outcome variable: Change in AHI (pre-post) with MMA surgery
Time frame: baseline (pre-operative), post surgery (6 months)
Secondary outcome variable: Failure of MMA surgery defined as AHI ≥ 15/hour
Primary predictor variable: Change in AHI, from baseline to maximal therapeutic protrusion, with RCMP study
Time frame: baseline (pre-operative), post surgery (6 months)
age, sex, BMI, AHI, retrognathia, airway collapse on forced inspiration, AHI reduction on RCMP titration and magnitude of advancement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Yes. We will share deidentified individual patient data which supports the results reported in research publications. The data will be published as supplemental files with the original publication.
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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.
Sharon Aronovich, DMD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RCMP titration in people with Obstructive Sleep Apnea and Maxillomandibular Advancement Surgery, run by University of Michigan at 1 site in United States.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Lay-Luskin (734-763-5963, jalay@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome variable: Change in AHI (pre-post) with MMA surgery (time frame: baseline (pre-operative), post surgery (6 months)). The study lists 2 primary outcomes in all. 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 9 Dec 2024.