Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT03929549
Status
Recruiting
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Conditions

  • Maxillomandibular Advancement Surgery
  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
30 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • RCMP titration — DEVICE
    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 Details

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.

Key Dates

Start date
Aug 12, 2019
Status verified
Dec 2024
Primary completion
Dec 31, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: RCMP titration
    Remotely Controlled Mandibular Positioner

Primary Outcome Measure

Primary outcome variable: Change in AHI (pre-post) with MMA surgery [ Time Frame: baseline (pre-operative), post surgery (6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Michigan Medicine Oral and Maxillofacial SurgeryAnn ArborMichigan48109
Jennifer a Lay-Luskin, MPhil
[email protected]
734-936-5950

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By research site
Michigan Medicine Oral and Maxillofacial Surgery· Ann Arbor, MI

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