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RECRUITING Not applicable ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07851480

Registry updated: 2026-10-01
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Description

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.

Interventions

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

Eligibility criteria

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

Conditions

PTSD - Post Traumatic Stress Disorder Trauma-related Nightmares

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record