Sleep Apnea Syndrome (OSAS)CMAINCT07596719
Natural History of Central and Mixed Sleep Apneas Followed by Maxillomandibular Advancement for Obstructive Sleep Apnea
An observational study of Sleep Apnea Syndrome (OSAS) and Central Sleep Apnea, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndrome (OSAS), Central Sleep Apnea, Maxillomandibular Advancement Surgery
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obstructive sleep apnea (OSA) patients who are present with maxillomandibular advancement (MMA) treatment-related central and mixed apneas.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Department of Oral and Maxillofacial Surgery
Amsterdam, North Holland, 1105 AZ
Dr. Ho, 020-5663898, j.p.ho@amsterdamumc.nl
About this study
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
- Sleep Apnea Syndrome (OSAS), Central Sleep Apnea, Maxillomandibular Advancement Surgery, Orthognathic Surgical Procedures
- Keywords
- OSA, MMA, Central Sleep Apnea
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with OSA who developed central and/or mixed sleep apneas after MMA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index (AHI)
Measured: 12 months after MMA surgery
Central apnea index (CAI)
Measured: 12 months after MMA surgery
Mixed apnea index (MAI)
Measured: 12 months after MMA surgery
The percentage of central and mixed apneas of AHI (CMAI%)
Measured: 12 months after MMA
Secondary outcomes (2)
Lowest oxyhemoglobin saturation (LSAT)
Measured: 12 months after MMA surgery
Oxygen desaturation index (ODI)
Measured: 12 months after MMA surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea Syndrome (OSAS)Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. J. de Lange, MD DMD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596719
- Sponsor's protocol ID
- NL80376.018.22
- Acronym
- CMAI
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Central and Mixed Sleep Apneas Followed by Maxillomandibular Advancement for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07596719
- Acronym / sponsor ID
- CMAI / NL80376.018.22
- Conditions
- Sleep Apnea Syndrome (OSAS), Central Sleep Apnea, Maxillomandibular Advancement Surgery, Orthognathic Surgical Procedures
- Keywords
- OSA, MMA, Central Sleep Apnea
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with OSA who developed central and/or mixed sleep apneas after MMA | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obstructive sleep apnea (OSA) patients who are present with maxillomandibular advancement (MMA) treatment-related central and mixed apneas.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Lowest oxyhemoglobin saturation (LSAT)
Time frame: 12 months after MMA surgery
Oxygen desaturation index (ODI)
Time frame: 12 months after MMA surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndrome (OSAS) and Central Sleep Apnea, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ho (020-5663898, j.p.ho@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (AHI) (time frame: 12 months after MMA surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.