Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder (SOMMEPT)

Post-Traumatic Stress Disorder (PTSD) is a public health problem due to both its chronic nature and the low response rate to conventional therapies.

Sleep disorders are the first cause of complaint in patients with PTSD due to night awakenings, difficulty to fall asleep and nightmares.

According to a part of the scientific community, replicative traumatic nightmares represent PTSD's basis mechanism. Traumatic nightmares generate disabling symptoms such as anxiety reactions, while maintaining the symptoms by depriving the individual of good quality sleep. Traumatic nightmares may thus be a sign of PTSD seriousness and chronicity, although their physiological basis remain poorly known.

In the military population, which is highly exposed to psychological traumatism, PTSD prevalence is very high and is associated with severe intensity patterns, a very high frequency of replicative nightmares and a low response to conventional therapies.

Study Overview

• Status: Recruiting
• Conditions: Post-traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Sleep recording; Behavioral: Cognitive tasks; Other: Questionnaires

• Study Type: Observational
• Enrollment (Estimated): 190

Contacts and Locations

• Study Contact: Name: Emeric SAGUIN, MD; Phone Number: +33 143985440; Email: emeric.saguin@intradef.gouv.fr

Study Locations

• France
  • Clamart, France, 92141
    • Recruiting
    • Hôpoital d'Instruction des Armées Percy
    • Contact: Marie BOUSSAUD, MD; Phone Number: +33 141466298; Email: marie.boussaud@intradef.gouv.fr
  • Mailly-le-Camp, France, 10230
    • Not yet recruiting
    • 52e Antenne Médicale
    • Contact: Pierre PERRIER, MD; Phone Number: +33 325472512; Email: pierre1.perrier@intradef.gouv.fr
  • Marseille, France, 13384
    • Recruiting
    • Hôpital d'Instruction des Armées Laveran
    • Contact: Frédéric PAUL, MD; Phone Number: +33 491617282; Email: frederic1.paul@intradef.gouv.fr
  • Mourmelon-le-Grand, France, 51400
    • Not yet recruiting
    • 29e Antenne Médicale
    • Contact: Gaetan SOYERE, MD; Phone Number: +33 326637438; Email: gaetan.soyere@intradef.gouv.fr
  • Saint-Mandé, France, 94160
    • Recruiting
    • Hopital d'Instruction des Armees BEGIN
    • Contact: Emeric SAGUIN, MD; Phone Number: +33 143985440; Email: emeric.saguin@intradef.gouv.fr
  • Toulon, France, 83000
    • Not yet recruiting
    • Hôpital d'Instruction des Armées Sainte-Anne
    • Contact: Charles GHEORGHIEV, MD; Phone Number: +33 483162159; Email: charles.gheorghiev@intradef.gouv.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of patients suffering from an active PTSD and healthy individuals.

Description

Inclusion Criteria:

• Military or former military
• Age between 18 and 65 years old
• PTSD group : with a PTSD diagnosis
• Control group : without any sleep, psychiatric or neurologic pathology

Exclusion Criteria:

• Diagnosis of progressive psychiatric pathology prior to the traumatic event responsible for PTSD
• Sleep pathology prior to the traumatic event responsible for PTSD
• Neurological pathology or severe head injury within the last 3 years

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PTSD patients; This group is composed of patients suffering from an active PTSD	Behavioral: Sleep recording; Sleep is recorded at home during 7 nights in a row using a connected headband. The participant also has to fill in a sleep agenda every day.; Behavioral: Cognitive tasks; Working memory and inhibition capacity is assessed during computer-based tasks (2-back and Go/No-Go tasks) at enrollment and 1 month after enrollment.; Other: Questionnaires; The participant has to fill in several questionnaires at enrollment and 1 month after enrollment in order to assess: PTSD severity; chronotype; Sleep quality; Daytime sleepiness; Mood state; Depression; Mental disorders and their consequences
Control group (healthy individuals); This group is composed of healthy individuals.	Behavioral: Sleep recording; Sleep is recorded at home during 7 nights in a row using a connected headband. The participant also has to fill in a sleep agenda every day.; Behavioral: Cognitive tasks; Working memory and inhibition capacity is assessed during computer-based tasks (2-back and Go/No-Go tasks) at enrollment and 1 month after enrollment.; Other: Questionnaires; The participant has to fill in several questionnaires at enrollment and 1 month after enrollment in order to assess: PTSD severity; chronotype; Sleep quality; Daytime sleepiness; Mood state; Depression; Mental disorders and their consequences

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with a Sleep Efficiency Index (SEI) < 80%.	The sleep efficiency index (SEI) is defined by the ratio TST/TIB with TST being Total Sleep Time and TIB being Time In Bed. TST and TIB will be assessed objectively, at home, using a connected headband (DREEM®, Rythm Paris). A Sleep Efficiency Index (SEI) < 80% is considered to be a poor quality, low-efficiency night.	1 month after enrollment

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Dyssomnias; Parasomnias
• Other Study ID Numbers: 2020PRI01; 2020-A01808-31 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No