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

Recruiting

• Conditions: Post-traumatic Stress Disorder

• Registration Number: NCT04581850
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-09
• Study Start: 2020-10-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with a Sleep Efficiency Index (SEI) < 80%.	1 month after enrollment	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.

Trial Locations

Locations (6)

Hôpoital d'Instruction des Armées Percy; 🇫🇷 Clamart, France

52e Antenne Médicale; 🇫🇷 Mailly-le-Camp, France

Hôpital d'Instruction des Armées Laveran; 🇫🇷 Marseille, France

29e Antenne Médicale; 🇫🇷 Mourmelon-le-Grand, France

Hôpital d'Instruction des Armées Bégin; 🇫🇷 Saint-Mandé, France

Hôpital d'Instruction des Armées Sainte-Anne; 🇫🇷 Toulon, France