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Recruiting NCT07851480

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

Conditions: PTSD - Post Traumatic Stress Disorder, Trauma-related Nightmares

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 27
Sponsor: Direction Centrale du Service de Santé des Armées

Location: Clermont Tonnerre Regional Military Teaching Hospital, psychiatry department Brest

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07851480). StuddyBuddy aggregates publicly available trial information.