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NCT Number: NCT07547501

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 2024.
  • Age ≥18 and ≤65 years at the time of the polysomnography recording.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Prediction accuracy of sleep stages and sub-stages

    Time frame: 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.

Secondary outcomes

  1. Prediction accuracy of chronic insomnia profiles

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

    Evaluation of the deep learning algorithms' accuracy in identifying and predicting chronic insomnia profiles based on the electroencephalographic (EEG) analysis of polysomnographies. Performance will be assessed by comparing the automated predictions against established clinical diagnoses using standard machine learning classification metrics (such as macro F1-score and Cohen's Kappa).

  2. Prediction accuracy of epilepsy profiles

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

    Evaluation of the deep learning algorithms' accuracy in identifying and predicting different epilepsy profiles based on the electroencephalographic (EEG) analysis of polysomnographies. Performance will be assessed by comparing the automated predictions against established clinical diagnoses using standard machine learning classification metrics (such as macro F1-score and Cohen's Kappa).

Study contacts

Contact information is provided by the study sponsor or research team.

Jinmi BAEK

CONTACT

[email protected]

Vincent Navarro, MD, PhD

CONTACT

[email protected]

+33 1 42 16 18 11

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Idiap Research Institute, Switzerland

Registry information

Acronym: PREDSomADICE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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