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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Dec 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how sleep inertia—often described as feeling groggy or sluggish right after waking up—affects people with Major Depressive Disorder (MDD). The researchers want to compare three groups: individuals with MDD who experience sleep inertia, those with MDD who do not, and individuals without mood disorders or sleep inertia. By looking at these different groups, the study aims to understand the relationship between sleep inertia and depression better.

To participate, individuals need to be between 18 and 65 years old and must be able to read and understand French. Those with MDD will need a diagnosis that meets specific criteria, while the control group must not have any mood or sleep disorders. Participants will first need to provide consent to join the study and complete several assessments related to their sleep and mood. The study is not yet recruiting participants, but if you or someone you know is interested, it's important to be aware that certain health conditions and medications may exclude individuals from participation.

Gender

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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.