Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)

Trial details

Who runs it

CHR Sambre et Meuse Site Meuse

Trial code

NCT07910461

Record updated

3 November 2026

Original description

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.Read full original descriptionShow less

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)

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.

Inclusion: Dentoskeletal deformity requiring bilateral sagittal split osteotomy with or without Le Fort I osteotomy after orthodontic-maxillofacial multidisciplinary assessment; Age 15 years or older at consent, with completed skeletal growth according to department practice; Positive two-step screening for sleep-disordered breathing risk: (1) STOP-BANG score >= 3 and/or high risk on the Berlin questionnaire; and (2) on the first Sunrise night at 1 month before surgery, AHI >= 5 events/h or REMOV >= 15% of total sleep time; Signed informed consent (co-signed by holders of parental authority for minors). - Ability to use the Sunrise device at home.

Exclusion: Medical or anesthetic contraindication to orthognathic surgery; Concurrent participation in another interventional study likely to interfere with sleep measurements or surgical outcomes; Syndromic craniofacial malformation (e.g., Crouzon syndrome, Pierre Robin sequence); Known allergy or skin intolerance to the Sunrise sensor materials or adhesive, or active dermatosis of the submental area; Known severe sleep-disordered breathing (AHI >= 30/h) treated preoperatively with CPAP or a mandibular advancement device; Current pregnancy or breastfeeding; Inability to comply with the planned visits and procedures.

ClinicalTrials.gov NCT07910461