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

NCT04581850 | Unknown

• 2 other identifiers: 2020PRI012020-A01808-31
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 6

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.

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PTSD patients

This group is composed of patients suffering from an active PTSD

Behavioral: Sleep recording; Behavioral: Cognitive tasks; Other: Questionnaires

Control group (healthy individuals)

This group is composed of healthy individuals.

Behavioral: Sleep recording; Behavioral: Cognitive tasks; Other: Questionnaires

Interventions

Sleep recording BEHAVIORAL

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.

Control group (healthy individuals); PTSD patients

Cognitive tasks BEHAVIORAL

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.

Control group (healthy individuals); PTSD patients

Questionnaires OTHER

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

Control group (healthy individuals); PTSD patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of patients suffering from an active PTSD and healthy individuals.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (6)

Hôpoital d'Instruction des Armées Percy

Clamart, 92141, France

RECRUITING

52e Antenne Médicale

Mailly-le-Camp, 10230, France

NOT YET RECRUITING

Hôpital d'Instruction des Armées Laveran

Marseille, 13384, France

RECRUITING

29e Antenne Médicale

Mourmelon-le-Grand, 51400, France

NOT YET RECRUITING

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, 94160, France

RECRUITING

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, 83000, France

NOT YET RECRUITING

Related Publications (1)

• Saguin 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.

  PMID: 40370761 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Emeric SAGUIN, MD

CONTACT

143985440; emeric.saguin@intradef.gouv.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 9, 2020
• Study Start: October 16, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

FR (6)