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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
Sponsor:
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

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
Post-traumatic Stress Disorder Behavioral: Sleep recording Behavioral: Cognitive tasks Other: Questionnaires

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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
    • chronotype
    • Sleep quality
    • Daytime sleepiness
    • Mood state
    • Depression
    • Mental disorders and their consequences


Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is composed of patients suffering from an active PTSD.
Criteria

Inclusion Criteria:

  • Military or former military
  • Age between 18 and 65 years old
  • with a PTSD diagnosis

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

Information from the National Library of Medicine

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


Contacts
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Contact: Emeric SAGUIN, MD 143985440 ext +33 emeric.saguin@intradef.gouv.fr

Locations
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France
Hôpoital d'Instruction des Armées Percy Not yet recruiting
Clamart, France, 92141
Contact: Marie-Dominique COLAS, MD, PhD    141466290 ext +33    marie-dominique.colas@intradef.gouv.fr   
Hôpital d'Instruction des Armées Laveran Not yet recruiting
Marseille, France, 13384
Contact: Frédéric PAUL, MD    491617282 ext +33    frederic1.paul@intradef.gouv.fr   
Hôpital d'Instruction des Armées Bégin Recruiting
Saint-Mandé, France, 94160
Contact: Emeric SAGUIN, MD    143985440 ext +33    emeric.saguin@intradef.gouv.fr   
Hôpital d'Instruction des Armées Sainte-Anne Not yet recruiting
Toulon, France, 83000
Contact: Charles GHEORGHIEV, MD    483162159 ext +33    charles.gheorghiev@intradef.gouv.fr   
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
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Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT04581850    
Other Study ID Numbers: 2020PRI01
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Sleep Wake Disorders
Nervous System Diseases