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

Post-traumatic Stress Disorder Clinical Trial

— SOMMEPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04581850
• Other study ID #: 2020PRI01
• Secondary ID: 2020-A01808-31
• Status: Recruiting
• Start date: October 16, 2020
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Emeric SAGUIN, MD
• Phone: 143985440
• Email: emeric.saguin[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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 chronotype Sleep quality Daytime sleepiness Mood state Depression Mental disorders and their consequences

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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