Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
Centre Hospitalier Universitaire de Nīmes
110 participants
Nov 4, 2025
OBSERVATIONAL
Conditions
Summary
The study population comprises three groups of 30 analyzable participants: Patients with sleep inertia and Major Depressive Disorder, patients with Major Depressive Disorder but without sleep inertia, and controls without mood disorders or sleep inertia. Controls will be patients referred to the Sleep Disorders and Acupuncture Unit for polysomnography as part of the screening process for a sleep disorder. Only controls presenting an apnea-hypopnea index \< 15/h, a periodic leg movements index during sleep \< 15/h and a total sleep time ≥ 6 hours on the video-polysomnography will be analyzed.
Eligibility
Inclusion Criteria16
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Diagnosis of depression according to DSM-5 criteria
- Suspicion of a sleep disorder requiring polysomnographic screening
- Score for IHSS items 3 and 4
- Score ≥ 1 for group with sleep inertia
- No complaints of sleep inertia (score = 0 on IHSS items 3 and 4)
- No excessive daytime sleepiness (Epworth Sleepiness Scale score ≤10),
- No depressive symptoms (Hospital Anxiety Depression Scale score \< 8 on items 2, 4, 6, 8, 10, 12, 14).
- Patients with central nervous system diseases: Parkinson's disease, mild cognitive impairment and dementia, progressive supranuclear palsy, multisystem atrophy, Huntington's chorea, amyotrophic lateral sclerosis, epilepsy, history of head trauma with loss of consciousness.
- Patients with a malignant neoplastic disease requiring therapeutic treatment in the 12months prior to the screening visit
- Other medical or psychiatric illnesses (with the exception of depression in he depression group) which, in the investigator's opinion, could interfere with the study.
- History of suicide attempt (including failed attempt), or suicidal ideation in the past month
- Chronic alcohol consumption or drug abuse in the previous 6 months
- Sleep-wake circadian rhythm disorders and presence of sleep insufficiency according to ICSD-3 criteria
- Pregnant, parturient or breast-feeding women.
Exclusion Criteria2
- The patient is participating in an interventional study
- The patient is under safeguard of justice or state guardianship
Interventions
Five PVT tests (before sleep at 7pm, 7am, 7:30am, 8am and 11am). The PVT is a 10-minute test designed to assess the vigilance and sustained attention by measuring reaction times (RT) to visual stimuli. During the test, participants are required to monitor the computer screen and press the response button as soon as a millisecond counter appears which will stop the counter and display the RT in milliseconds. The stimuli are randomly presented.
Performed overnight as part of routine care (11 p.m. to 7 a.m.).
Actimeter and sleep diary to assess the sleep-wake patterns of the participants in their natural environments over a two-week period.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06732284