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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
Sponsor: Direction Centrale du Service de Santé des Armées
Summary
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 study, one month later) at one of the three participating military hospitals The algorithm will be applied to the recorded data after collection and does not intervene in real time or affect participants' standard medical care in any way.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
27
Start Date
2026-04-30
Completion Date
2027-10
Last Updated
2026-10-01
Healthy Volunteers
No
Interventions
CAUD-PIN (CAUchemar Detection on INdividualized Parameters) - AI-based predictive algorithm forTrauma-related nightmare awakenings
CAUD-PIN (CAUchemar Detection on INdividualized Parameters) is a non-invasive, AI-based predictive algorithm developed by the VIFASOM research team (UMR 7330, Université Paris Cité / French Military Health Service) from the SOMMEPT clinical project. It analyzes multimodal physiological signals recorded during home sleep to identify patterns preceding Trauma-related nightmare awakenings in military patients with PTSD. Data are collected using two wearable devices: an EEG headband (Hypnodyne Zmax Lite) measuring brain activity and sleep stages, and a wrist-worn multisensor bracelet (Empatica EmbracePlus) measuring heart rate, electrodermal activity, skin temperature, and motor activity. The algorithm is applied exclusively post-hoc to pseudonymized recordings, with no real-time intervention and no impact on participants' standard medical care.
Locations (3)
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, Île-de-France Region, France