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NCT Number: NCT07596719

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

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)

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Key information

Conditions

Sleep Apnea Syndrome (OSAS) Apnea Central Sleep Apnea Dyssomnias Maxillomandibular Advancement Surgery Nervous System Diseases Orthognathic Surgical Procedures Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oral and Maxillofacial Surgery

Amsterdam, North Holland, 1105 AZ, Netherlands

Location contact

Dr. Ho

CONTACT

[email protected]

020-5663898

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Apnea-hypopnea index (AHI)

    Time frame: 12 months after MMA surgery

  2. Central apnea index (CAI)

    Time frame: 12 months after MMA surgery

  3. Mixed apnea index (MAI)

    Time frame: 12 months after MMA surgery

  4. The percentage of central and mixed apneas of AHI (CMAI%)

    Time frame: 12 months after MMA

Secondary outcomes

  1. Lowest oxyhemoglobin saturation (LSAT)

    Time frame: 12 months after MMA surgery

  2. Oxygen desaturation index (ODI)

    Time frame: 12 months after MMA surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Ho

CONTACT

[email protected]

020-5663898

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: CMAI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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