Natural History of Central and Mixed Sleep Apneas Followed by Maxillomandibular Advancement for O… (NCT07596719) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Natural History of Central and Mixed Sleep Apneas Followed by Maxillomandibular Advancement for Obstructive Sleep Apnea
Netherlands60 participantsStarted 2026-12-01
Plain-language summary
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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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;
* Patients who are present with MMA treatment-related central apneas postoperatively
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Apnea-hypopnea index (AHI)
Timeframe: 12 months after MMA surgery
2
Central apnea index (CAI)
Timeframe: 12 months after MMA surgery
3
Mixed apnea index (MAI)
Timeframe: 12 months after MMA surgery
4
The percentage of central and mixed apneas of AHI (CMAI%)
Timeframe: 12 months after MMA
Trial details
NCT IDNCT07596719
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)