Recruiting

RCMP

Sponsor:

University of Michigan

Code:

NCT03929549

Conditions

Obstructive Sleep Apnea

Maxillomandibular Advancement Surgery

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

Interventions

RCMP titration

Study Details

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

Study ID

NCT03929549

Start date

Aug 12, 2019

Status verified date

Dec, 2024

Completion date

Jul, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

AHI ≥ 15/hour

30-65 years of age

BMI 25-34.9

Ideal operative candidate

Unable or unwilling to use PAP

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: RCMP titration

Remotely Controlled Mandibular Positioner

Interventions

RCMP titration

An overnight titration polysomnogram with gradual mandibular protrusion and assessment of polysomnographic parameters (i.e. AHI, oxygen saturation, etc.) at various magnitudes of protrusion.

Primary outcome measure

  • Primary outcome variable: Change in AHI (pre-post) with MMA surgery [ Time Frame: baseline (pre-operative), post surgery (6 months) ]
  • Primary predictor variable: Change in AHI, from baseline to maximal therapeutic protrusion, with RCMP study [ Time Frame: baseline (pre-operative), post surgery (6 months) ]

Central Contacts and Locations

Central contacts

Jennifer Lay-Luskin

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

Locations

Michigan Medicine Oral and Maxillofacial Surgery

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jennifer a Lay-Luskin, MPhil

734-936-5950jalay@med.umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Dec 9, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2024-12-09.