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

NCT07596719 | Not Yet Recruiting DMC

• 1 other identifier: NL80376.018.22
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

OSA; MMA; Central Sleep Apnea

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Lowest oxyhemoglobin saturation (LSAT)

  12 months after MMA surgery

• Oxygen desaturation index (ODI)

  12 months after MMA surgery

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Dr. Ho

CONTACT

020-5663898; j.p.ho@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)