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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04581850
Acronym
SOMMEPT
Enrollment
190
Registered
2020-10-09
Start date
2020-10-16
Completion date
2024-10-31
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic Stress Disorder

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.

Interventions

BEHAVIORALSleep 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.

BEHAVIORALCognitive 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.

OTHERQuestionnaires

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

Direction Centrale du Service de Santé des Armées
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of subjects with a Sleep Efficiency Index (SEI) < 80%.1 month after enrollmentThe 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.

Countries

France

Contacts

Primary ContactEmeric SAGUIN, MD
emeric.saguin@intradef.gouv.fr143985440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026