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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Adults with OSA who developed central and/or mixed sleep apneas after MMA

Trial outcomes

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

Other outcomes

Sponsors and contacts

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