Treatment Failure of Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea Syndrome (OSA): A Trial Comparing Polysomnography and the Sunrise Device to Drive Treatment-Adjustment Decisions.

Official title

Treatment Failure of Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea Syndrome (OSA): A Randomized Controlled Trial Comparing Polysomnography and the Sunrise Device to Drive Treatment-Adjustment Decisions.

Overview

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: * Do Sunrise-based assessments lead to similar therapeutic decisions as PSG-based assessments? * Are residual apnea-hypopnea indices measured by Sunrise comparable to those measured by PSG? Participants will complete both assessment sequences in a randomized cross-over design. They will: * Use the Sunrise device for several nights with and without CPAP. * Undergo one night of PSG with and without CPAP. * Have their CPAP therapy reviewed based on the results of each assessment method.

Detailed description

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:

1. Sunrise assessments first, consisting of several nights with and without CPAP, followed by one night of PSG with and without CPAP; or 2. PSG assessments first, followed by the Sunrise sequence.

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.

Interventions

• Device Sunrise
  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.

Primary outcome measures

• Cohen's Kappa for Agreement Between Therapeutic Adjustment Decisions Based on Sunrise and Polysomnography (PSG) [Time frame: Within 1 night for each modality (Sunrise home recording and in-lab PSG).]

Secondary outcome measures (3)

• Cohen's Kappa for Agreement Between Therapeutic Adjustment Decisions Based on Three-Night Sunrise Recordings and Polysomnography (PSG) [Time frame: 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) [Time frame: 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 [Time frame: One in-lab PSG night; one or three consecutive home nights with Sunrise.]

Eligibility criteria

Inclusion criteria

• Adults aged 18 to 85 years
• Patients treated with Resmed CPAP
• Residual apnea-hypopnea index under CPAP (rAHI(CPAP) > 10 events/hour)
• Access to a smartphone and home internet connection, and ability to use a mobile application
• Signed informed consent
• Affiliated with, or beneficiary of, a national health insurance program

Exclusion criteria

• Severe chronic obstructive or restrictive pulmonary disease, with or without supplemental oxygen
• Unstable cardiovascular disease or severe heart failure requiring hospitalization within the past 3 months, or meeting New York Heart Association (NYHA) class III or IV criteria
• Conditions affecting mandibular condyle rotation or temporomandibular joint function
• Refusal to shave excessive facial hair when required for proper placement of the Sunrise device
• Participation in another interventional clinical study or currently within an exclusion period of another study
• Individuals who, in the investigator's judgment, are unlikely to comply with study procedures or requirements
• Individuals who cannot be contacted in case of emergency
• Persons protected under French Public Health Code articles L1121-5, L1121-6, and L1121-8 (including pregnant or breastfeeding women, persons deprived of liberty, individuals under psychiatric care under articles L.3212-1 or L.3213-1, individuals admitted to healthcare or social institutions for reasons other than research, and persons under legal protection or unable to provide informed consent)
• Staff members with a hierarchical relationship to the principal investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• CHU Grenoble Alpes — Grenoble

Publications

• 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. PMID 25367475
• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. PMID 2868172
• 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. PMID 38593278
• 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. PMID 37767856
• 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. PMID 35444480
• 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. PMID 38330168
• 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. PMID 35368281
• 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. PMID 39047815

Identifiers

NCT: NCT07530302 · 38RC25.0313

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗