Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder
NCT ID: NCT04581850
Last Updated: 2023-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
190 participants
OBSERVATIONAL
2020-10-16
2024-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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PTSD patients
This group is composed of patients suffering from an active PTSD
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.
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.
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
Control group (healthy individuals)
This group is composed of healthy individuals.
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.
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.
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
Interventions
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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.
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.
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
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 65 years old
* PTSD group : with a PTSD diagnosis
* Control group : without any sleep, psychiatric or neurologic pathology
Exclusion Criteria
* Sleep pathology prior to the traumatic event responsible for PTSD
* Neurological pathology or severe head injury within the last 3 years
18 Years
65 Years
ALL
No
Sponsors
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Direction Centrale du Service de Santé des Armées
OTHER
Responsible Party
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Locations
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Hôpoital d'Instruction des Armées Percy
Clamart, , France
52e Antenne Médicale
Mailly-le-Camp, , France
Hôpital d'Instruction des Armées Laveran
Marseille, , France
29e Antenne Médicale
Mourmelon-le-Grand, , France
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, , France
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Saguin E, Feingold D, Sipahimalani G, Quiquempoix M, Roseau JB, Remadi M, Annette S, Guillard M, Van Beers P, Lahutte B, Leger D, Gomez-Merino D, Chennaoui M. PTSD Symptom Severity Associated With Sleep Disturbances in Military Personnel: Evidence From a Prospective Controlled Study With Ecological Recordings. Depress Anxiety. 2025 Apr 25;2025:8011375. doi: 10.1155/da/8011375. eCollection 2025.
Other Identifiers
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2020-A01808-31
Identifier Type: OTHER
Identifier Source: secondary_id
2020PRI01
Identifier Type: -
Identifier Source: org_study_id
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