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

May 13, 2026 updated by: Prof. dr. J. de Lange, MD DMD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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)

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Department of Oral and Maxillofacial Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Obstructive sleep apnea (OSA) patients who are present with maxillomandibular advancement (MMA) treatment-related central and mixed apneas.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adults with OSA who developed central and/or mixed sleep apneas after MMA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL80376.018.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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