SOMMEPT: Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with a Sleep Efficiency Index (SEI) < 80%. [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Military or former military
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Age between 18 and 65 years old
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with a PTSD diagnosis
Exclusion Criteria:
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Diagnosis of progressive psychiatric pathology prior to the traumatic event responsible for PTSD
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Sleep pathology prior to the traumatic event responsible for PTSD
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Neurological pathology or severe head injury within the last 3 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpoital d'Instruction des Armées Percy | Clamart | France | 92141 | |
| 2 | Hôpital d'Instruction des Armées Laveran | Marseille | France | 13384 | |
| 3 | Hôpital d'Instruction des Armées Bégin | Saint-Mandé | France | 94160 | |
| 4 | Hôpital d'Instruction des Armées Sainte-Anne | Toulon | France | 83000 |
Sponsors and Collaborators
- Direction Centrale du Service de Santé des Armées
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020PRI01
- 2020-A01808-31