NCT04581850

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 190 (estimated)
• Sponsor: Direction Centrale du Service de Santé des Armées · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-traumatic Stress Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-10-16
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2020-10-09
• Last updated: 2023-09-18

Locations

6 sites across 1 country: France