Developing a Sleep Algxorithm to Support a Digital Medicine System: Noninterventional, Observational Sleep Study
Notice bibliographique
Résumé
Background: Sleep-wake patterns are important behavioral biomarkers for patients with serious mental illness (SMI), providing insight into their well-being. The gold standard for monitoring sleep is polysomnography (PSG), which requires a sleep lab facility; however, advances in wearable sensor technology allow for real-world sleep-wake monitoring. Objective: The goal of this study was to develop a PSG-validated sleep algorithm using accelerometer (ACC) and electrocardiogram (ECG) data from a wearable patch to accurately quantify sleep in a real-world setting. Methods: In this noninterventional, nonsignificant-risk, abbreviated investigational device exemption, single-site study, participants wore the reusable wearable sensor version 2 (RW2) patch. The RW2 patch is part of a digital medicine system (aripiprazole with sensor) designed to provide objective records of medication ingestion for patients with schizophrenia, bipolar I disorder, and major depressive disorder. This study developed a sleep algorithm from patch data and did not contain any study-related or digitized medication. Patch-acquired ACC and ECG data were compared against PSG data to build machine learning classification models to distinguish periods of wake from sleep. The PSG data provided sleep stage classifications at 30-second intervals, which were combined into 5-minute windows and labeled as sleep or wake based on the majority of sleep stages within the window. ACC and ECG features were derived for each 5-minute window. The algorithm that most accurately predicted sleep parameters against PSG data was compared to commercially available wearable devices to further benchmark model performance. Results: Of 80 participants enrolled, 60 had at least 1 night of analyzable ACC and ECG data (25 healthy volunteers and 35 participants with diagnosed SMI). Overall, 10,574 valid 5-minute windows were identified (5854 from participants with SMI), and 84% (n=8830) were classified as greater than half sleep. Of the 3 models tested, the conditional random field algorithm provided the most robust sleep-wake classification. Performance was comparable to the middle 50% of commercial devices evaluated in a recent publication, providing a sleep detection performance of 0.93 (sensitivity) and wake detection performance of 0.60 (specificity) at a prediction probability threshold of 0.75. The conditional random field algorithm retained this performance for individual sleep parameters, including total sleep time, sleep efficiency, and wake after sleep onset (within the middle 50% to top 25% of the assessed devices). The only parameter where the model performance was lower was sleep onset latency (within the bottom 25% of all comparator devices). Conclusions: Using industry-best practices, we developed a sleep algorithm for use with the RW2 patch that can accurately detect sleep and wake windows compared to PSG-labeled sleep data. This algorithm may be used for a more complete understanding of well-being for patients with SMI in a real-world setting, without the need for PSG and a sleep lab.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,011 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».