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

NCT04581850 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 190

Last updated 2023-09-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Direction Centrale du Service de Santé des Armées

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-16
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04581850 on ClinicalTrials.gov