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| Name | Class |
|---|---|
| Polyclinique Saint Laurent - Rennes | UNKNOWN |
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The goal of this clinical trial is to determine whether treatment-adjustment decisions based on one night of home monitoring with the Sunrise device are comparable to decisions based on one night of in-laboratory polysomnography (PSG) in adults with obstructive sleep apnea (OSA) who remain insufficiently controlled with continuous positive airway pressure (CPAP) therapy.
The main questions it aims to answer are:
Participants will complete both assessment sequences in a randomized cross-over design. They will:
Obstructive sleep apnea (OSA) affects nearly one billion adults worldwide and is associated with recurrent upper-airway obstruction during sleep, leading to intermittent hypoxemia and multiple cardiometabolic and neurocognitive comorbidities. Continuous positive airway pressure (CPAP) is the standard treatment and is widely prescribed, with more than 1.8 million users in France. Despite its proven efficacy, large-scale analyses show that over 10% of treated patients continue to exhibit elevated residual apnea-hypopnea indices (AHI), a situation associated with reduced adherence and premature discontinuation of therapy.
Evaluation of CPAP effectiveness typically relies on in-laboratory polysomnography (PSG), which remains the reference method for characterizing residual respiratory events and sleep architecture. However, the need for PSG generates substantial healthcare costs, long waiting times, and unequal access to diagnostic resources.
The Sunrise device is a CE-marked medical device that records mandibular movements during sleep and uses artificial intelligence to characterize respiratory events and sleep parameters. Multiple validation studies have demonstrated strong agreement between Sunrise-derived metrics and PSG.
This randomized cross-over trial investigates whether Sunrise can be used to guide therapeutic decisions in patients with insufficiently controlled OSA under CPAP therapy, defined by a residual AHI greater than 10 events per hour. Participants are randomized to one of two sequences:
This design allows each participant to serve as their own control and enables direct comparison of treatment-adjustment decisions derived from Sunrise versus PSG. The study aims to determine whether a home-based, low-burden assessment could replace or reduce the need for in-laboratory evaluations, thereby improving access to care, reducing costs, and facilitating personalized CPAP management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSG-SUN | Other | Participants will first undergo an overnight, in-laboratory polysomnography (PSG) in the sleep center. After this in-lab recording period, they will complete an at-home sleep assessment using the Sunrise device over the predefined home recording period. |
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| SUN-PSG | Other | Participants will first complete an at-home sleep assessment using the Sunrise device over the predefined home recording period. After this home recording period, they will undergo an overnight, in-laboratory polysomnography (PSG) in the sleep center. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunrise | Device | The Sunrise device is a single-use, mandibular movement-based sleep monitoring sensor designed to assess sleep architecture and respiratory events at home. In this study, Sunrise is evaluated as an alternative to in-laboratory polysomnography (PSG), which is considered the current gold-standard reference for sleep assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohen's Kappa for Agreement Between Therapeutic Adjustment Decisions Based on Sunrise and Polysomnography (PSG) | Agreement between therapeutic adjustment decisions derived from Sunrise home recordings and in-lab polysomnography (PSG), quantified using Cohen's kappa coefficient. Two independent experts will provide decisions for each modality; disagreements will be resolved by consensus. The therapeutic decision is a three-category variable: No change in CPAP treatment, adjustment of CPAP pressure or change of mask, switch to servo-ventilation if residual events are predominantly central. | Within 1 night for each modality (Sunrise home recording and in-lab PSG). |
| Measure | Description | Time Frame |
|---|---|---|
| Cohen's Kappa for Agreement Between Therapeutic Adjustment Decisions Based on Three-Night Sunrise Recordings and Polysomnography (PSG) | Agreement between therapeutic adjustment decisions derived from three consecutive nights of Sunrise home recordings and in-lab polysomnography (PSG), quantified using Cohen's kappa coefficient. Two independent experts will provide decisions for each modality; disagreements will be resolved by consensus. The therapeutic decision is a three-category variable: No change in CPAP treatment, adjustment of CPAP pressure or change of mask, switch to servo-ventilation if residual events are predominantly central. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie JOYEUX-FAURE, Pr | Contact | +33(0)476767166 | MJoyeuxfaure@chu-grenoble.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble Alpes | Recruiting | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25367475 | Background | Sateia MJ. International classification of sleep disorders-third edition: highlights and modifications. Chest. 2014 Nov;146(5):1387-1394. doi: 10.1378/chest.14-0970. | |
| 2868172 | Background | Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. |
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|
| Three consecutive home nights for Sunrise recordings and one in-lab PSG night. |
| Agreement Between PSG-Measured rAHI and Sunrise-Measured rAHI (One Night and Three Nights) | This outcome evaluates the concordance between the residual Apnea-Hypopnea Index (rAHI) measured by:
For each modality, rAHI values will be interpreted by two independent experts, blinded to the results of the other method. In case of disagreement between the two experts for a given modality, they will meet to reach a consensus rAHI interpretation, following the same adjudication procedure as for the primary outcome. The analysis will compare rAHI obtained from PSG with rAHI obtained from Sunrise over one night and over three nights to assess the level of agreement between modalities. | One in-lab PSG night; one or three consecutive home nights with Sunrise. |
| Inter-Rater Agreement Between the Two Independent Experts for Therapeutic Adjustment Decisions | For each participant and for each assessment modality (in-lab PSG, one-night Sunrise recording, and three-night Sunrise recording), the therapeutic adjustment decision will be independently provided by Expert 1 and Expert 2, each blinded to the other's evaluation. The therapeutic decision is a three-category variable:
This outcome measures the inter-rater agreement between the two experts for each modality, based on their initial independent decisions (before any consensus meeting). | One in-lab PSG night; one or three consecutive home nights with Sunrise. |
| 38593278 | Background | Cassibba J, Aubertin G, Martinot JB, Le Dong N, Hullo E, Beydon N, Dupont-Athenor A, Mortamet G, Pepin JL. Analysis of mandibular jaw movements to assess ventilatory support management of children with obstructive sleep apnea syndrome treated with positive airway pressure therapies. Pediatr Pulmonol. 2024 Jul;59(7):1905-1911. doi: 10.1002/ppul.27005. Epub 2024 Apr 9. |
| 37767856 | Background | Malhotra A, Martinot JB, Pepin JL. Insights on mandibular jaw movements during polysomnography in obstructive sleep apnea. J Clin Sleep Med. 2024 Jan 1;20(1):151-163. doi: 10.5664/jcsm.10830. |
| 35444480 | Background | Pepin JL, Le-Dong NN, Cuthbert V, Coumans N, Tamisier R, Malhotra A, Martinot JB. Mandibular Movements are a Reliable Noninvasive Alternative to Esophageal Pressure for Measuring Respiratory Effort in Patients with Sleep Apnea Syndrome. Nat Sci Sleep. 2022 Apr 13;14:635-644. doi: 10.2147/NSS.S346229. eCollection 2022. |
| 38330168 | Background | Pepin JL, Cistulli PA, Crespeigne E, Tamisier R, Bailly S, Bruwier A, Le-Dong NN, Lavigne G, Malhotra A, Martinot JB. Mandibular Jaw Movement Automated Analysis for Oral Appliance Monitoring in Obstructive Sleep Apnea: A Prospective Cohort Study. Ann Am Thorac Soc. 2024 May;21(5):814-822. doi: 10.1513/AnnalsATS.202312-1077OC. |
| 35368281 | Background | Kelly JL, Ben Messaoud R, Joyeux-Faure M, Terrail R, Tamisier R, Martinot JB, Le-Dong NN, Morrell MJ, Pepin JL. Diagnosis of Sleep Apnoea Using a Mandibular Monitor and Machine Learning Analysis: One-Night Agreement Compared to in-Home Polysomnography. Front Neurosci. 2022 Mar 15;16:726880. doi: 10.3389/fnins.2022.726880. eCollection 2022. |
| 39047815 | Background | Alsaif SS, Douglas W, Steier J, Morrell MJ, Polkey MI, Kelly JL. Mandibular movement monitor provides faster, yet accurate diagnosis for obstructive sleep apnoea: A randomised controlled study. Clin Med (Lond). 2024 Jul;24(4):100231. doi: 10.1016/j.clinme.2024.100231. Epub 2024 Jul 22. |
| 29198291 | Background | Pepin JL, Woehrle H, Liu D, Shao S, Armitstead JP, Cistulli PA, Benjafield AV, Malhotra A. Adherence to Positive Airway Therapy After Switching From CPAP to ASV: A Big Data Analysis. J Clin Sleep Med. 2018 Jan 15;14(1):57-63. doi: 10.5664/jcsm.6880. |
| 33667996 | Background | Midelet A, Borel JC, Tamisier R, Le Hy R, Schaeffer MC, Daabek N, Pepin JL, Bailly S. Apnea-hypopnea index supplied by CPAP devices: time for standardization? Sleep Med. 2021 May;81:120-122. doi: 10.1016/j.sleep.2021.02.019. Epub 2021 Feb 16. |
| 36470417 | Background | Bottaz-Bosson G, Midelet A, Mendelson M, Borel JC, Martinot JB, Le Hy R, Schaeffer MC, Samson A, Hamon A, Tamisier R, Malhotra A, Pepin JL, Bailly S. Remote Monitoring of Positive Airway Pressure Data: Challenges, Pitfalls, and Strategies to Consider for Optimal Data Science Applications. Chest. 2023 May;163(5):1279-1291. doi: 10.1016/j.chest.2022.11.034. Epub 2022 Dec 2. |
| 33804319 | Background | Pepin JL, Bailly S, Rinder P, Adler D, Szeftel D, Malhotra A, Cistulli PA, Benjafield A, Lavergne F, Josseran A, Tamisier R, Hornus P, On Behalf Of The medXcloud Group. CPAP Therapy Termination Rates by OSA Phenotype: A French Nationwide Database Analysis. J Clin Med. 2021 Mar 1;10(5):936. doi: 10.3390/jcm10050936. |
| 28629918 | Background | Liu D, Armitstead J, Benjafield A, Shao S, Malhotra A, Cistulli PA, Pepin JL, Woehrle H. Trajectories of Emergent Central Sleep Apnea During CPAP Therapy. Chest. 2017 Oct;152(4):751-760. doi: 10.1016/j.chest.2017.06.010. Epub 2017 Jun 16. |
| 27188535 | Background | Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15. |
| 31300334 | Background | Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9. |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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