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

NCT07851480 | Recruiting

• 1 other identifier: 2025PBMD01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

PTSD - Post Traumatic Stress Disorder; Trauma-related Nightmares

Keywords

Post-Traumatic Stress Disorder (PTSD); Trauma-related nightmares; Sleep disorders; Artificial Intelligence; Machine Learning; Wearable Devices; Physiological Monitoring; Physiological signal processing; Sleep Recording; Military Personnel; Veterans; Ecological Momentary Assessment (EMA); Predictive Algorithm; Translational Research

Outcome Measures

Primary Outcomes (1)

• Sensitivity of the CAUD-PIN algorithm in predicting Trauma-related nightmare awakenings

  Sensitivity will be calculated as the number of Trauma-related nightmare awakenings correctly identified by the CAUD-PIN algorithm divided by the total number of confirmed trauma-related nightmare awakenings, multiplied by 100. Unit of Measure: Percentage

  During the 15 consecutive nights of home sleep recording

Secondary Outcomes (34)

• Specificity of the CAUD-PIN algorithm for predicting Trauma-related nightmare awakenings

  During the 15 consecutive nights of home sleep recording

• Positive predictive value of the CAUD-PIN algorithm

  During the 15 consecutive nights of home sleep recording

• Negative predictive value of the CAUD-PIN algorithm

  During the 15 consecutive nights of home sleep recording

• Prediction lead time before trauma-related nightmare awakening

  Through 15 nights of recording

• Intra- and inter-individual variability in heart rate preceding trauma-related nightmare awakenings

  During the 15 consecutive nights of home sleep recording

Study Arms (1)

CAUD-PIN Validation Group

EXPERIMENTAL

French Military personnel and/or veterans with PTSD wear two non-invasive wearable devices at home - an EEG headband (Hypnodyne Zmax Lite) and a multisensor bracelet (Empatica EmbracePlus) - for 15 consecutive nights. Participants press a button on the bracelet to report each nightmare-related awakening. Physiological data are analyzed post-hoc by the CAUD-PIN algorithm to validate its ability to predict trauma-related nightmare awakenings. Two clinical assessments are conducted at enrollment and at study completion.

Diagnostic Test: CAUD-PIN (CAUchemar Detection on INdividualized Parameters) - AI-based predictive algorithm forTrauma-related nightmare awakenings

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.

CAUD-PIN Validation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (3)

Clermont Tonnerre Regional Military Teaching Hospital, psychiatry department

Brest, 29200, France

RECRUITING

Percy National Military Teaching Hospital, Department of Psychiatry

Clamart, 92190, France

NOT YET RECRUITING

Bégin National Military Teaching Hospital

Saint-Mandé, Île-de-France Region, 94160, France

RECRUITING

Related Publications (4)

• Feingold D, Roseau JB, Verdonk C, Richards A, Chennaoui M, Saguin E, Leger D. Trauma-related nightmares: A Comprehensive and Integrative review. Sleep Med Rev. 2026 Jun;87:102259. doi: 10.1016/j.smrv.2026.102259. Epub 2026 Feb 18.

  PMID: 41886932 BACKGROUND

• Feingold D, Quiquempoix M, Remadi M, Sipahimalani G, Lahutte B, Leger D, Gomez-Merino D, Chennaoui M, Saguin E. Physiological markers of Trauma-related nightmares among military personnel suffering from PTSD: A multicenter home-recording study. Psychiatry Clin Neurosci. 2026 May;80(5):398-408. doi: 10.1111/pcn.70038. Epub 2026 Feb 14.

  PMID: 41689450 BACKGROUND

• Saguin E, Feingold D, Sipahimalani G, Quiquempoix M, Roseau JB, Remadi M, Annette S, Guillard M, Van Beers P, Lahutte B, Leger D, Gomez-Merino D, Chennaoui M. PTSD Symptom Severity Associated With Sleep Disturbances in Military Personnel: Evidence From a Prospective Controlled Study With Ecological Recordings. Depress Anxiety. 2025 Apr 25;2025:8011375. doi: 10.1155/da/8011375. eCollection 2025.

  PMID: 40370761 BACKGROUND

• Saguin E, Feingold D, Roseau JB, Quiquempoix M, Boussaud M, Izabelle C, Metlaine A, Guillard M, Van Beers P, Gheorghiev C, Lahutte B, Leger D, Gomez-Merino D, Chennaoui M. An ecological approach to clinically assess nightmares in military service members with severe PTSD. Sleep Med. 2023 Mar;103:78-88. doi: 10.1016/j.sleep.2023.01.024. Epub 2023 Jan 28.

  PMID: 36764045 BACKGROUND

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emeric SAGUIN, MD, PhD

  Department of Psychiatry, Begin National Military Teaching Hospital, Saint-Mandé, 94160, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emeric SAGUIN, MD, PhD

CONTACT

+33 01 43 98 54 40; emeric.saguin@intradef.gouv.fr

Dorone FEINGOLD, Msc

CONTACT

+33 6 51 11 19 56; dorone.feingold@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: October 1, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)