About this trial
The goal of this observational prospective cohort study is to learn about the natural course of central and mixed sleep apneas that develop after maxillomandibular advancement (MMA) surgery for obstructive sleep apnea (OSA) in adult patients.
The main question it aims to answer is:
Do central and mixed apneas resolve, partially resolve, or persist in the long term after MMA?
Participants will:
Undergo a first postoperative polysomnography (PSG) at 3-6 months after MMA (part of standard care).
Be invited into the study if central/mixed apneas are detected (CMAI% \>25%). Undergo a second PSG at least 12 months after MMA (extra study procedure)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older;
Mild to severe OSA as determined by a polysomnography (PSG) preoperatively;
Completion of MMA for OSA treatment;
Subjects with preoperative and postoperative PSG;
Disqualifiers
Patients who underwent other adjunctive procedures at the time of MMA (e.g., multi-piece Le Fort osteotomy, TMJ reconstruction);
Previous history of orthognathic surgery;
Cleft palate and syndromic patients.
Trial population
Obstructive sleep apnea (OSA) patients who are present with maxillomandibular advancement (MMA) treatment-related central and mixed apneas.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Apnea-hypopnea index (AHI)
Central apnea index (CAI)
Mixed apnea index (MAI)
The percentage of central and mixed apneas of AHI (CMAI%)
Secondary outcomes
Lowest oxyhemoglobin saturation (LSAT)
Oxygen desaturation index (ODI)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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