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Peer-reviewedCC BYThe Lancet Regional Health - Europe

Time to diagnosis and treatment of obstructive sleep apnoea using mandibular jaw movement monitoring versus polysomnography: an open-label, multicentre, randomised, controlled trial

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60 listed; 77 in total.

Abstract

Background: Obstructive sleep apnoea (OSA) is often underdiagnosed, highlighting the need for scalable diagnostic alternatives. The SUNSAS study compared a new device for at-home diagnosis of OSA (artificial intelligence [AI]-supported analysis of mandibular jaw movements [MJM]) with polysomnography (PSG) for time to diagnosis and treatment, and patient-reported outcomes. Methods: This prospective, multicentre, randomised, controlled, open-label study was conducted in France (October 2021-October 2024). Adults aged 18-80 years with suspected OSA were randomised (1:1) to undergo diagnostic testing using MJM monitoring (Sunrise) or PSG. Primary endpoints were assessed using hierarchical testing: 1. daytime sleepiness (Epworth Sleepiness Scale [ESS] score) at 3 months post-diagnosis and time to diagnosis; 2. time to treatment; and 3. daytime sleepiness at 3 months post-randomisation. Secondary endpoints included quality of life (Short Form-36, Quebec Sleep Questionnaire), work productivity (Work Productivity and Activity Impairment questionnaire), and positive airway pressure therapy adherence at 3 months after treatment initiation. Findings: , apnoea-hypopnoea index 15·2/h), 774 received a diagnosis: 133 no OSA, 239 mild OSA, 220 moderate OSA, and 182 severe OSA. Median time to diagnosis (15 vs. 106 days) and to treatment initiation (50 vs. 124 days) were significantly shorter with MJM analysis versus PSG (both p < 0·01). MJM-based diagnosis was noninferior to PSG in reducing ESS at 3 months after diagnosis (-2·26 vs. -2·29; 95% confidence interval [CI] for difference -0·85, 0·79; p = 0·01), and superior at 3 months post-randomisation (between-group difference: -1·51 (95% CI -2·17, -0·85); p < 0·01). Secondary endpoints also favoured the MJM group. Interpretation: OSA diagnosis based on MJM monitoring with AI-supported analysis is noninferior to PSG in reducing daytime sleepiness at 3 months after diagnosis, while significantly accelerating time to diagnosis and treatment initiation, resulting in earlier improvement in daytime sleepiness. Funding: programme.

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BibTeX
@article{pepin2026time,
  title = {{Time to diagnosis and treatment of obstructive sleep apnoea using mandibular jaw movement monitoring versus polysomnography: an open-label, multicentre, randomised, controlled trial}},
  author = {Jean-Louis Pépin and Renaud Tamisier and Marc Manceau and Katleen Denoncin and Arnaud Prigent and Maxime Patout and Hervé Pégliasco and Frédéric Gagnadoux and Jean-Benoît Martinot and Matthieu Roustit and Sarah Alexandre and Sébastien Baillieul and Lucie Barateau and Clara Bianquis and Yvan Bellanger and Hélène Benzaquen and Laurent Boyer and Nicolas Carpentier and Elena Charbonnier and Ari Chaouat and Rita Clin and Julien Coelho and Ala Covali and Yves Dauvilliers and Claire Denis and Marie Destors and Marie Pia D’ortho and Antoine Dumazet and Justine Frija and Sacha Gaillard and Thibaut Gentina and Maëlle Guellerin and Kelly Guichard and Laurence Hertert-Gandolfo and Benjamin Huret and Antoine Jaffiol and François Jounieaux and Philippe Lang and Claire Launois and Damien Léger and Smaranda Leu-Semenescu and Rim Leymarie and Cécile Londner and Quentin Lorber and Marie-Noëlle Lothe-Cartier and Régis Luraine and Guillaume Marchand and Nicole Meslier and Jean-Arthur Micoulaud-Franchi and Pierre-Jean Monteyrol and Pauline Mulette and Marina Ogier and Cécile Olivier and Caroline Pagniez and Albert Pajon and Yasmina Pascaud-Mansour and Laure Peter-Derex and Pierre Philip and Carole Planès and Sandrine Pontier-Marchandise},
  journal = {The Lancet Regional Health - Europe},
  year = {2026},
  month = aug,
  doi = {10.1016/j.lanepe.2026.101637},
  url = {https://hal.science/hal-05732868v1},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Time to diagnosis and treatment of obstructive sleep apnoea using mandibular jaw movement monitoring versus polysomnography: an open-label, multicentre, randomised, controlled trial
AU  - Jean-Louis Pépin
AU  - Renaud Tamisier
AU  - Marc Manceau
AU  - Katleen Denoncin
AU  - Arnaud Prigent
AU  - Maxime Patout
AU  - Hervé Pégliasco
AU  - Frédéric Gagnadoux
AU  - Jean-Benoît Martinot
AU  - Matthieu Roustit
AU  - Sarah Alexandre
AU  - Sébastien Baillieul
AU  - Lucie Barateau
AU  - Clara Bianquis
AU  - Yvan Bellanger
AU  - Hélène Benzaquen
AU  - Laurent Boyer
AU  - Nicolas Carpentier
AU  - Elena Charbonnier
AU  - Ari Chaouat
AU  - Rita Clin
AU  - Julien Coelho
AU  - Ala Covali
AU  - Yves Dauvilliers
AU  - Claire Denis
AU  - Marie Destors
AU  - Marie Pia D’ortho
AU  - Antoine Dumazet
AU  - Justine Frija
AU  - Sacha Gaillard
AU  - Thibaut Gentina
AU  - Maëlle Guellerin
AU  - Kelly Guichard
AU  - Laurence Hertert-Gandolfo
AU  - Benjamin Huret
AU  - Antoine Jaffiol
AU  - François Jounieaux
AU  - Philippe Lang
AU  - Claire Launois
AU  - Damien Léger
AU  - Smaranda Leu-Semenescu
AU  - Rim Leymarie
AU  - Cécile Londner
AU  - Quentin Lorber
AU  - Marie-Noëlle Lothe-Cartier
AU  - Régis Luraine
AU  - Guillaume Marchand
AU  - Nicole Meslier
AU  - Jean-Arthur Micoulaud-Franchi
AU  - Pierre-Jean Monteyrol
AU  - Pauline Mulette
AU  - Marina Ogier
AU  - Cécile Olivier
AU  - Caroline Pagniez
AU  - Albert Pajon
AU  - Yasmina Pascaud-Mansour
AU  - Laure Peter-Derex
AU  - Pierre Philip
AU  - Carole Planès
AU  - Sandrine Pontier-Marchandise
PY  - 2026
DA  - 2026/08/31
JO  - The Lancet Regional Health - Europe
DO  - 10.1016/j.lanepe.2026.101637
UR  - https://hal.science/hal-05732868v1
AB  - Background: Obstructive sleep apnoea (OSA) is often underdiagnosed, highlighting the need for scalable diagnostic alternatives. The SUNSAS study compared a new device for at-home diagnosis of OSA (artificial intelligence [AI]-supported analysis of mandibular jaw movements [MJM]) with polysomnography (PSG) for time to diagnosis and treatment, and patient-reported outcomes. Methods: This prospective, multicentre, randomised, controlled, open-label study was conducted in France (October 2021-October 2024). Adults aged 18-80 years with suspected OSA were randomised (1:1) to undergo diagnostic testing using MJM monitoring (Sunrise) or PSG. Primary endpoints were assessed using hierarchical testing: 1. daytime sleepiness (Epworth Sleepiness Scale [ESS] score) at 3 months post-diagnosis and time to diagnosis; 2. time to treatment; and 3. daytime sleepiness at 3 months post-randomisation. Secondary endpoints included quality of life (Short Form-36, Quebec Sleep Questionnaire), work productivity (Work Productivity and Activity Impairment questionnaire), and positive airway pressure therapy adherence at 3 months after treatment initiation. Findings: , apnoea-hypopnoea index 15·2/h), 774 received a diagnosis: 133 no OSA, 239 mild OSA, 220 moderate OSA, and 182 severe OSA. Median time to diagnosis (15 vs. 106 days) and to treatment initiation (50 vs. 124 days) were significantly shorter with MJM analysis versus PSG (both p < 0·01). MJM-based diagnosis was noninferior to PSG in reducing ESS at 3 months after diagnosis (-2·26 vs. -2·29; 95% confidence interval [CI] for difference -0·85, 0·79; p = 0·01), and superior at 3 months post-randomisation (between-group difference: -1·51 (95% CI -2·17, -0·85); p < 0·01). Secondary endpoints also favoured the MJM group. Interpretation: OSA diagnosis based on MJM monitoring with AI-supported analysis is noninferior to PSG in reducing daytime sleepiness at 3 months after diagnosis, while significantly accelerating time to diagnosis and treatment initiation, resulting in earlier improvement in daytime sleepiness. Funding: programme.
SN  - 2666-7762
ER  -