PREDiction of Different Variants of Sleep Stages for the Diagnosis Support of Chronic Insomnia an… (NCT07547501) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PREDiction of Different Variants of Sleep Stages for the Diagnosis Support of Chronic Insomnia and Epilepsy
1,500 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prediction accuracy of sleep stages and sub-stages
Timeframe: Single overnight polysomnography recording per participant (duration of approximately 8 to 12 hours)