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临床试验/NCT07547501
NCT07547501尚未招募不适用

PREDiction of Different Variants of Sleep Stages for the Diagnosis Support of Chronic Insomnia and Epilepsy

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 1,500 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,500
主要终点
Prediction accuracy of sleep stages and sub-stages

研究概览

简要总结

The objective of this study is to develop and validate deep learning algorithms for automated sleep stage and sub-stage classification using overnight polysomnography data. The models will be trained and evaluated on at least three independent datasets to ensure generalizability.

- Primary Outcome Measure : Accuracy of deep learning-based sleep stage classification compared to expert manual scoring (>80% target agreement), evaluated across multiple polysomnography datasets including AP-HP (Assistance Publique - Hôpitaux de Paris) data.

This is a retrospective, observational study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with chronic insomnia and/or epilepsy who underwent polysomnography in a neurophysiology or neurology setting under the responsibility of Pr Navarro between 01 September 2011 and 31 December
  • Age ≥18 and ≤65 years at the time of the polysomnography recording.

排除标准

  • Severe psychiatric disorder, including decompensated psychotic disorder, manic episode, or major depressive episode with melancholic features.
  • Use of continuous positive airway pressure (CPAP) therapy during the night of recording.
  • Patient refusal or documented opposition to data use.

结局指标

主要结局

Prediction accuracy of sleep stages and sub-stages

时间窗: Single overnight polysomnography recording per participant (duration of approximately 8 to 12 hours)

Evaluation of the deep learning model's performance in accurately classifying different sleep stages and sub-stages compared to expert manual scoring. The metrics used to characterize this outcome are the macro F1-score and/or Cohen's Kappa (κ) score, with a target prediction accuracy of \>80%. The macro F1-score measures the model's ability to correctly recognize each sleep stage while compensating for the imbalance between frequent and rare classes. Cohen's Kappa quantifies the degree of agreement between automatic predictions and human annotations by correcting for the agreement expected by chance. The combination of these two metrics offers a robust and balanced evaluation.

次要结局

  • Prediction accuracy of chronic insomnia profiles(Single overnight polysomnography recording per participant (duration of approximately 8 to 12 hours))
  • Prediction accuracy of epilepsy profiles(Single overnight polysomnography recording per participant (duration of approximately 8 to 12 hours))

研究者

申办方类型
Other
责任方
Sponsor

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