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

Overview

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.

Interventions

• Other 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.
• Other Video-polysomnography
  Performed overnight as part of routine care (11 p.m. to 7 a.m.).
• Other 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.

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

France · 1 center

• CHU de Nimes — Nîmes

Identifiers

NCT: NCT06732284 · NIMAO/2023-2/EE-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗