Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task (IN-DEP)

Centre Hospitalier Universitaire de Nīmes

Status

Enrolling

Conditions

Major Depression

Sleep Inertia

Treatments

Other: Sleep and activity monitoring

Other: Psychomotor vigilance task

Other: Video-polysomnography

Study type

Observational

Funder types

Other

Identifiers

NCT06732284

NIMAO/2023-2/EE-01

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

18 to 54 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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
Ability to understand, write and read French Inclusion criteria for patients with major depression
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
- Score = 0 for the group without sleep inertia Inclusion criteria for controls
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).

Exclusion criteria

The patient is participating in an interventional study
The patient is under safeguard of justice or state guardianship
Unweaned from the following medications for at least 5 half-lives prior to inclusion: wake-promoting or psychostimulant drugs (modafinil, methylphenidate, mazindol, amphetamine, pitolisant, solriamfetol, sodium oxybate), neuroleptics, hypnotics, antidepressants, anxiolytics, antiepileptics, budipine, dopamine agonist and antagonist antiemetics (except domperidone), opiates, gabapentin, pregabalin, benzodiazepines, Z-hypnotics (zolpidem and zopiclone), monoamine oxidase inhibitors, catechol-O-methyltransferase or sedative antihistamines.
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.