Menu
Not yet recruiting NCT07596719

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sleep Apnea Syndrome (OSAS), Central Sleep Apnea, Maxillomandibular Advancement Surgery, Orthognathic Surgical Procedures. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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)

Primary outcome measures

  • Apnea-hypopnea index (AHI) [Time frame: 12 months after MMA surgery]
  • Central apnea index (CAI) [Time frame: 12 months after MMA surgery]
  • Mixed apnea index (MAI) [Time frame: 12 months after MMA surgery]
  • The percentage of central and mixed apneas of AHI (CMAI%) [Time frame: 12 months after MMA]
Secondary outcome measures (2)
  • Lowest oxyhemoglobin saturation (LSAT) [Time frame: 12 months after MMA surgery]
  • Oxygen desaturation index (ODI) [Time frame: 12 months after MMA surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Department of Oral and Maxillofacial Surgery — Amsterdam

Identifiers

NCT: NCT07596719 · NL80376.018.22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗