Post-traumatic Stress DisorderSOMMEPTNCT04581850
Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder
An observational study of Post-traumatic Stress Disorder, run by Direction Centrale du Service de Santé des Armées at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Sleep recording, Cognitive tasks and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 190 participants
- Where
- 6 sitesFrance
- Study dates
- 16 Oct 2020to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is composed of patients suffering from an active PTSD and healthy individuals.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Hôpoital d'Instruction des Armées Percy
Clamart, 92141
Marie BOUSSAUD, MD, 141466298 ext. +33, marie.boussaud@intradef.gouv.fr
- Not yet recruiting
52e Antenne Médicale
Mailly-le-Camp, 10230
Pierre PERRIER, MD, 325472512 ext. +33, pierre1.perrier@intradef.gouv.fr
- Recruiting
Hôpital d'Instruction des Armées Laveran
Marseille, 13384
Frédéric PAUL, MD, 491617282 ext. +33, frederic1.paul@intradef.gouv.fr
- Not yet recruiting
29e Antenne Médicale
Mourmelon-le-Grand, 51400
Gaetan SOYERE, MD, 326637438 ext. +33, gaetan.soyere@intradef.gouv.fr
- Recruiting
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160
Emeric SAGUIN, MD, 143985440 ext. +33, emeric.saguin@intradef.gouv.fr
- Not yet recruiting
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83000
Charles GHEORGHIEV, MD, 483162159 ext. +33, charles.gheorghiev@intradef.gouv.fr
About this study
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.
Read more
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.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Sleep recording, Cognitive tasks, Questionnaires
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep recordingBehavioural
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 tasksBehavioural
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.
QuestionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| PTSD patients | This group is composed of patients suffering from an active PTSD Receives: Behavioral: Sleep recording; Behavioral: Cognitive tasks; Other: Questionnaires | |
| Control group (healthy individuals) | This group is composed of healthy individuals. Receives: Behavioral: Sleep recording; Behavioral: Cognitive tasks; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start16 Oct 2020
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581850
- Sponsor's protocol ID
- 2020PRI01
- Other IDs
- 2020-A01808-31
- Acronym
- SOMMEPT
- Status last verified
- Sep 2023
- First submitted
- 5 Oct 2020
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Feingold D, Quiquempoix M, Remadi M, Sipahimalani G, Lahutte B, Leger D, Gomez-Merino D, Chennaoui M, Saguin E. Physiological markers of Trauma-related nightmares among military personnel suffering from PTSD: A multicenter home-recording study. Psychiatry Clin Neurosci. 2026 May;80(5):398-408. doi: 10.1111/pcn.70038. Epub 2026 Feb 14.
PubMed 41689450Saguin 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.
PubMed 40370761
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep Disturbance as a Biomarker of Disease Activity in a Military Population With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04581850
- Acronym / sponsor ID
- SOMMEPT / 2020PRI01
- Conditions
- Post-traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTSD patients | – | Behavioral: Sleep recording, Behavioral: Cognitive tasks, Other: QuestionnairesThis group is composed of patients suffering from an active PTSD |
| Control group (healthy individuals) | – | Behavioral: Sleep recording, Behavioral: Cognitive tasks, Other: QuestionnairesThis group is composed of healthy individuals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of patients suffering from an active PTSD and healthy individuals.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep recordingSleep 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. | Behavioural | Control group (healthy individuals), PTSD patients |
| Cognitive tasksWorking memory and inhibition capacity is assessed during computer-based tasks (2-back and Go/No-Go tasks) at enrollment and 1 month after enrollment. | Behavioural | Control group (healthy individuals), PTSD patients |
| QuestionnairesThe 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 | Other | Control group (healthy individuals), PTSD patients |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 41689450Feingold D, Quiquempoix M, Remadi M, Sipahimalani G, Lahutte B, Leger D, Gomez-Merino D, Chennaoui M, Saguin E. Physiological markers of Trauma-related nightmares among military personnel suffering from PTSD: A multicenter home-recording study. Psychiatry Clin Neurosci. 2026 May;80(5):398-408. doi: 10.1111/pcn.70038. Epub 2026 Feb 14.
- Derived from this study: PubMed 40370761Saguin 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.
- Individual participant dataSharing planned: Undecided
Related trials for Post-traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-traumatic Stress Disorder, run by Direction Centrale du Service de Santé des Armées at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emeric SAGUIN, MD (143985440 ext. +33, emeric.saguin@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with a Sleep Efficiency Index (SEI) < 80%. (time frame: 1 month after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581850, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.