New splintless jaw surgery could improve sleep apnea treatment
NCT ID NCT07598461
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a newer 'splintless' jaw surgery is more accurate and safer than the standard method for treating obstructive sleep apnea. About 66 adults with moderate to severe sleep apnea who cannot use CPAP will be randomly assigned to one of the two surgeries. Researchers will measure how precisely the jaws are moved, along with safety and cost, over several years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Splintless maxillomandibular advancement surgery
- What this could lead to
- If successful, this could make jaw surgery for sleep apnea more precise and safer, potentially improving outcomes and reducing complications.
- What could go wrong
- This is a small, early-stage trial with only 66 participants, so results may not apply to everyone. The surgery itself carries risks like infection or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: For OSA patients: * Adults aged 18 years or older; * Moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15 events/hour) as determined by an overnight polysomnography (PSG) preoperatively; * Continunous positive airway pressure failure or intolerance; * General good health for surgery; * MMA surgery indicated for OSA treatment. For bedpartners of patients: • Sharing a bed ⩾2 nights/week with patient. Exclusion Criteria: For OSA patients: * Other adjunctive procedures indicated at the time of MMA (e.g., multi-piece Le Fort I osteotomy, temporomandibular joint reconstruction); * Previous history of orthognathic surgery; * Cleft palate and syndromic patients; * Refusal to participate. For bedpartners of patients: • Refusal to participate.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Oral and Maxillofacial Surgery, Amsterdam UMC
Amsterdam, North Holland, 1105 AZ, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Which jaw surgery cut keeps the jaw in place longer?
- Which jaw surgery method spares the joint? a Head-to-Head test
- Can a new pressure relief mode outperform standard therapy for sleep apnea?
- Freezing away sleep apnea: a new procedure targets throat fat to open the airway