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

Study Overview
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Brief Summary
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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.

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

Conditions
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Post-traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Sleep recording
* Behavioral: Cognitive tasks
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PTSD patients<br>This group is composed of patients suffering from an active PTSD | Behavioral: Sleep recording<br>* 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.<br>Behavioral: Cognitive tasks<br>* 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.<br>Other: Questionnaires<br>* 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<br>|
| Control group (healthy individuals)<br>This group is composed of healthy individuals. | Behavioral: Sleep recording<br>* 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.<br>Behavioral: Cognitive tasks<br>* 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.<br>Other: Questionnaires<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a Sleep Efficiency Index (SEI) < 80%. | 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. | 1 month after enrollment |