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Validation of an Algorithm for Predicting Awakenings Associated With Trauma-related Nightmares, Based on the Analysis of Physiological Patterns in Military and Former Military Patients Suffering From Post-traumatic Stress Disorder

RecruitingNAAges 18 Years - 65 YearsAllDirection Centrale du Service de Santé des Armées
NCT07851480 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to validate an artificial intelligence algorithm called CAUD-PIN (CAUchemar Detection on INdividualized Parameters) to predict nightmare-related awakenings in military personnel and veterans suffering from post-traumatic stress disorder (PTSD). The main question it aim to answer is : * Can the CAUD-PIN algorithm detect physiological patterns preceding trauma-related nightmare awakenings with a sensitivity greater than 80%? * What physiological signals best predict the occurrence of a trauma-related nightmare awakening? Participants will: Wear two non-invasive devices at home - an EEG headband and a wrist-worn sensor bracelet - for 15 consecutive nights Press a button on the bracelet each time they wake up from a nightmare Complete sleep and daytime diaries every evening and morning Attend two clinical assessments (at enrollment and at the end of the

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age between 18 and 65 years (age limit related to military status) * Active military personnel or veterans * Receiving psychiatric care in a military hospital (HNIA Bégin, HNIA Percy, or HRIA Brest) for PTSD related to combat trauma (exposure to death or life-threatening situations) * PCL-5 score \> 33 * Written informed consent obtained * Trauma-related nightmares occurring ≥ 4 times per week Exclusion Criteria: * Pre-existing progressive psychiatric disorder prior to trauma (condition requiring long-term treatment \> 1 year) * Sleep disorder affecting sleep architecture (obstructive sleep apnea syndrome, narcolepsy) * Neurological disorder (acute confusional state, severe traumatic brain injury) Inability to provide informed consent * Persons under legal protection measures (guardianship, curatorship, or equivalent judicial protection) * Persons not affiliated with a social security scheme
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What it tests

  • CAUD-PIN (CAUchemar Detection on INdividualized Parameters) - AI-based predictive algorithm forTrauma-related nightmare awakenings
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Where

3 sites
Clermont Tonnerre Regional Military Teaching Hospital, psychiatry department
Brest, France
Percy National Military Teaching Hospital, Department of Psychiatry
Clamart, France
Bégin National Military Teaching Hospital
Saint-Mandé, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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