Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task

Обзор

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.

Вмешательства

• Другое Psychomotor vigilance task
  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.
• Другое Video-polysomnography
  Performed overnight as part of routine care (11 p.m. to 7 a.m.).
• Другое Sleep and activity monitoring
  Actimeter and sleep diary to assess the sleep-wake patterns of the participants in their natural environments over a two-week period.

Первичные конечные точки

• Level of vigilance and sustained attention before and after sleep between groups [Срок оценки: Pre-sleep at 7pm and the wake-up measurements at 7am, 7:30am, 8am and 11am]

Вторичные конечные точки (12)

• The severity of sleep inertia in patients with major depression and sleep inertia [Срок оценки: Day 0]
• Age [Срок оценки: Day 0]
• Sex [Срок оценки: Day 0]
• BMI (Body Mass Index) [Срок оценки: Day 0]
• Age of onset and duration of mood disorder in both patient groups [Срок оценки: Day 0]
• Total sleep time (TTS) [Срок оценки: Day 0]
• Sleep efficiency (SE) [Срок оценки: Day 0]
• Sleep onset latency [Срок оценки: Day 0]
• Percentage in sleep stage (N1, N2, N3, SP) during the night and in the hour before waking up [Срок оценки: Day 0]
• Wake after sleep onset (WASO) [Срок оценки: Day 0]
• Microarousal index [Срок оценки: Day 0]
• Apnea-hypopnea index (AHI) [Срок оценки: Day 0]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• CHU de Nimes — Nîmes

Идентификаторы

NCT: NCT06732284 · NIMAO/2023-2/EE-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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