daytime sleepiness, Snoring daytime sleepiness, Snoring
Conditions
Interventions
In the intervention group, splintless MMA will be performed as an experimental
treatment. In the control group, conventional MMA using surgical splints (i.e.,
splint MMA) will be executed.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older; Moderate to severe OSA 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the accuracies of MMA surgical movements in anteroposterior translation and counterclockwise rotation of the maxilla and mandible. This makes a total of four primary study variables. | — |
Secondary
| Measure | Time frame |
|---|---|
| A) Other translation parameters (mediolateral, superoinferior) of the maxilla and mandible, and rotation parameters (roll, yaw) of the maxilla and mandible; B) Duration of surgery; C) Blood loss during surgery; D) Intra- and post-operative adverse events/complications; E) Sleep study measures; F) Daytime sleepiness as assessed with Epworth sleep scale (ESS); G) Functional status as assessed with Functional Outcomes of Sleep Questionnaire (FOSQ); H) Sleep quality as assessed with Pittsburgh Sleep Quality Index (PSQI); I) Patient*s health status as assessed with EuroQoL 5-dimension 5-level questionnaire (EQ-5D-5L); J) Quality of life as assessed with 36-Item Short Form Survey (SF-36); K) Patient*s satisfaction with facial appearance as assessed with FACE-Q; L) Patient*s satisfaction with surgery outcomes as assessed with customized patient satisfaction questionnaire; M) Bed partner*s opinion on patient*s surgery outcomes as assessed with bed partner questionnaire; N) Postsurgical relapse measures in translation parameters and rotation parameters of the maxilla and mandible; O) Facial soft tissue changes following MMA at various soft-tissue points using 3D tereophotogrammetry; P) Upper airway variables on CT; Q) Computational fluid dynamics derived parameters; R) Blood pressure; S) Incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR). | — |
Countries
Netherlands
Contacts
Public ContactN Zhou
Amsterdam UMC
Outcome results
None listed