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.
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
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
Crossover
Sunrise
DeviceThe 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.
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.
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.
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: * in-lab polysomnography (PSG) during one night (gold standard), * the Sunrise device during the first home night, * the Sunrise device across three consecutive home nights. 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.
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: * No change in CPAP treatment, * Adjustment of CPAP pressure or change of mask, * Switch to servo-ventilation if residual events are predominantly central. This outcome measures the inter-rater agreement between the two experts for each modality, based on their initial independent decisions (before any consensus meeting).
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University Hospital, Grenoble
Lead sponsor
Polyclinique Saint Laurent - Rennes
Collaborator
