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NCT03929549 · ClinicalTrials.gov registry record · NA

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

A NA study of Obstructive Sleep Apnea and Maxillomandibular Advancement Surgery, sponsored by University of Michigan.

Recruiting
Registry status
NA
Development phase
20
Enrollment target
1
Study location

NCT03929549 is a NA study of Obstructive Sleep Apnea and Maxillomandibular Advancement Surgery that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 20 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03929549, a NA study of Obstructive Sleep Apnea and Maxillomandibular Advancement Surgery, is actively recruiting participants, sponsored by University of Michigan.

RECRUITING
Registry status
NA
Development phase
20 participants
Enrollment target
1
Study location

Study 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 Studied

Obstructive Sleep Apnea Maxillomandibular Advancement Surgery

Interventions

  • DEVICE RCMP titration

Study Locations (1)

Michigan

  • Michigan Medicine Oral and Maxillofacial Surgery - Ann Arbor

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2019-08-12
Est. Completion 2026-07
Phase NA

Sponsor

University of Michigan

1,327 total trials

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What the Registry Record Tells You About NCT03929549

The ClinicalTrials.gov registry entry for NCT03929549 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (91% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which RCMP titration is the first listed.

NCT03929549 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.

Frequently Asked Questions

What is clinical trial NCT03929549 about?

NCT03929549 is a clinical study titled "Preliminary Evaluation of a RCMP to Predict Failure of Maxillomandibular Advancement Surgery for OSA". 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 facia...

What is the current status of trial NCT03929549?

This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2019-08-12. Estimated completion is 2026-07.

What conditions does trial NCT03929549 study?

This clinical trial studies the following conditions: Obstructive Sleep Apnea, Maxillomandibular Advancement Surgery.

What interventions are being tested in trial NCT03929549?

The interventions under investigation include: RCMP titration (DEVICE).

Who is sponsoring clinical trial NCT03929549?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03929549 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.