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Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Sponsor: CHR Sambre et Meuse Site Meuse
Summary
Orthognathic surgery changes the skeletal framework of the upper airway, but its functional effect on sleep-disordered breathing remains poorly documented, particularly with respect to respiratory effort. This prospective, exploratory, single-center pilot study will describe changes in the apnea-hypopnea index (AHI) and in respiratory effort burden (REMOV, percentage of total sleep time with increased respiratory effort) measured with the Sunrise mandibular jaw movement (MJM) home sleep monitoring device, from 1 month before to 6 months after orthognathic surgery (bilateral sagittal split osteotomy with or without Le Fort I osteotomy). Twenty-five patients aged 15 years or older, scheduled for orthognathic surgery as part of standard care at CHR Sambre et Meuse (Namur, Belgium) and screened positive for sleep-disordered breathing risk, will be included. Results will be used to generate hypotheses and to size a future confirmatory study.
Official title: Effects of Orthognathic Surgery on Respiratory Effort Burden in Obstructive Sleep Apnea Assessed by Indices Derived From Mandibular Jaw Movement Monitoring: A Prospective Exploratory Single-Center Pilot Study (SUNRISE-ORTHO-NAMUR)
Key Details
Gender
All
Age Range
15 Years - Any
Study Type
OBSERVATIONAL
Enrollment
25
Start Date
2026-11-04
Completion Date
2027-09-15
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
Orthognathic surgery (BSSO with or without Le Fort I osteotomy)
Standard-of-care orthognathic surgery under general anesthesia, mandible-first sequence, planned with 3D virtual surgical planning (IPS CaseDesigner, KLS Martin) and in-house printed splints. Not assigned by the study protocol.
Sunrise mandibular jaw movement monitoring
Chin-mounted MJM sensor (Sunrise, Namur, Belgium) used at home for two consecutive nights before surgery and two consecutive nights 6 months after surgery to derive respiratory and sleep indices.
Facial multidetector CT in natural head position
Facial CT at 1 month before and 6 months after surgery for 3D upper airway volume analysis; field restricted to the facial skeleton, dose optimized.
Locations (1)
CHR Sambre et Meuse - Site Meuse, Avenue Albert Ier 185, Namur, 5000, Belgium
Namur, Namur, Belgium