Natural History of Central and Mixed Sleep Apneas Followed by Maxillomandibular Advancement for Obstructive Sleep Apnea

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07596719

Acronym

CMAI

Enrollment

Registered

2026-05-19

Start date

2026-12-01

Completion date

2027-12-31

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sleep Apnea, Maxillomandibular Advancement Surgery, Orthognathic Surgical Procedures, Sleep Apnea Syndrome (OSAS)

Keywords

OSA, MMA, Central Sleep Apnea

Brief 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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Apnea-hypopnea index (AHI)	12 months after MMA surgery
Central apnea index (CAI)	12 months after MMA surgery
Mixed apnea index (MAI)	12 months after MMA surgery
The percentage of central and mixed apneas of AHI (CMAI%)	12 months after MMA

Secondary

Measure	Time frame
Lowest oxyhemoglobin saturation (LSAT)	12 months after MMA surgery
Oxygen desaturation index (ODI)	12 months after MMA surgery

Countries

Netherlands

Contacts

CONTACTDr. Ho

j.p.ho@amsterdamumc.nl020-5663898

Outcome results