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

NCT03929549 | Recruiting FDA Device

• 2 other identifiers: HUM00143739M-ROSA trial
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obstructive Sleep Apnea; Maxillomandibular Advancement Surgery

Outcome Measures

Primary Outcomes (2)

• Primary outcome variable: Change in AHI (pre-post) with MMA surgery

  Secondary outcome variable: Failure of MMA surgery defined as AHI ≥ 15/hour

  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.

  baseline (pre-operative), post surgery (6 months)

Study Arms (1)

RCMP titration

EXPERIMENTAL

Remotely Controlled Mandibular Positioner

Device: RCMP titration

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.

Also known as: Remotely Controlled Mandibular Positioner

RCMP titration

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AHI ≥ 15/hour
• years of age
• BMI 25-34.9
• Ideal operative candidate
• Unable or unwilling to use PAP

You may not qualify if:

• 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
• Inability to protrude the mandible beyond 5 mm
• Inability to follow-up after surgery
• Dental disorders including loose teeth or advanced periodontal disease

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Medicine Oral and Maxillofacial Surgery

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Sharon Aronovich, DMD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Lay-Luskin

CONTACT

734-763-5963; jalay@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Dentistry, Department of Oral and Maxillofacial Surgery, School of Dentistry and Assistant Professor of Oral Surgery

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: August 12, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Upon publication (Deidentified individual patient data may be published as supplemental files to an original research paper)
• Access Criteria: Deidentified individual patient data shared with a published paper will be published as supplemental files with the original publication

Locations

US (1)