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

D

Direction Centrale du Service de Santé des Armées

Status

Enrolling

Conditions

Post-traumatic Stress Disorder

Treatments

Behavioral: Sleep recording
Behavioral: Cognitive tasks
Other: Questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT04581850
2020PRI01
2020-A01808-31 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

190 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

190 participants in 2 patient groups

PTSD patients
Description:
This group is composed of patients suffering from an active PTSD
Treatment:
Behavioral: Cognitive tasks
Behavioral: Sleep recording
Other: Questionnaires
Control group (healthy individuals)
Description:
This group is composed of healthy individuals.
Treatment:
Behavioral: Cognitive tasks
Behavioral: Sleep recording
Other: Questionnaires

Trial contacts and locations

6

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Central trial contact

Emeric SAGUIN, MD

Data sourced from clinicaltrials.gov

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