Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder (SOMMEPT)
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|ClinicalTrials.gov Identifier: NCT04581850|
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : October 20, 2020
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.
|Condition or disease||Intervention/treatment|
|Post-traumatic Stress Disorder||Behavioral: Sleep recording Behavioral: Cognitive tasks Other: Questionnaires|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder|
|Actual Study Start Date :||October 16, 2020|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
- 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
- Sleep quality
- Daytime sleepiness
- Mood state
- Mental disorders and their consequences
- Proportion of subjects with a Sleep Efficiency Index (SEI) < 80%. [ Time Frame: 1 month after enrollment ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581850
|Contact: Emeric SAGUIN, MD||143985440 ext +email@example.com|
|Hôpoital d'Instruction des Armées Percy||Not yet recruiting|
|Clamart, France, 92141|
|Contact: Marie-Dominique COLAS, MD, PhD 141466290 ext +33 firstname.lastname@example.org|
|Hôpital d'Instruction des Armées Laveran||Not yet recruiting|
|Marseille, France, 13384|
|Contact: Frédéric PAUL, MD 491617282 ext +33 email@example.com|
|Hôpital d'Instruction des Armées Bégin||Recruiting|
|Saint-Mandé, France, 94160|
|Contact: Emeric SAGUIN, MD 143985440 ext +33 firstname.lastname@example.org|
|Hôpital d'Instruction des Armées Sainte-Anne||Not yet recruiting|
|Toulon, France, 83000|
|Contact: Charles GHEORGHIEV, MD 483162159 ext +33 email@example.com|