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Not yet recruitingNCT07596719CMAIUpdated May 19, 2026

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

An observational study in Sleep Apnea Syndrome (OSAS), Central Sleep Apnea and Maxillomandibular Advancement Surgery, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Sleep Apnea Syndromes with a site in Netherlands — 4 open to participants now, 4 under way, none of them phase 3. Sleep Apnea Syndromes · Netherlands.

Started
2026
with 1 other
Observational
5 of 10
3 open now
Registered
10th of 10
by date
Lead sponsor
3 of 10
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Among the 10 studies in Sleep Apnea Syndromes with a site in Netherlands, this one is one of 2 that started in 2026, is one of 5 observational ones, and was the 10th registered.

Sleep Apnea Syndromes

1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.

This study's planned enrollment of 60 is below the median of 150 across 343 observational studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Open to participants now

4 of the 10 studies in Sleep Apnea Syndromes with a site in Netherlands are open now.

All 4 open studies →

A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →

Who these studies take

Of the 117 Sleep Apnea Syndromes studies recruiting now, 57 (49%) set no upper age limit and 36 (31%) stop at 75 or younger; 24 take children under 18; 27 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Sleep Apnea Syndromes with a site in Netherlands, or all of them as a file.
02

Study 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)

03

Conditions studied

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

Keywords

  • OSA
  • MMA
  • Central Sleep Apnea
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adults with OSA who developed central and/or mixed sleep apneas after MMA
06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.

Of 130 non-industry observational studies under Sleep Apnea Syndromes, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 83. This study's planned 12 months is below that.

Counting every sponsor, half of 149 studies reached it within 43 months; a quarter within 15 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2026
First posted
May 19, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
May 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07596719
Responsible party
Prof. dr. J. de Lange, MD DMD (Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
May 19, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 19, 2026

Study contacts

Dr. Ho
Contact
j.p.ho@amsterdamumc.nl
020-5663898

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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