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Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task | Clinical Trials | Clareo Health

RECRUITING

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

NCT06732284•Centre Hospitalier Universitaire de Nīmes

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

Age

18 - 54 years

Sex

ALL

Healthy Volunteers

Yes

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
•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).

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.

Locations (1)

CHU de Nimes

Nîmes, France

Key Dates

Start Date

November 4, 2025

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

December 11, 2025

Enrollment

110

ESTIMATED participants

Conditions

Major DepressionSleep Inertia

Interventions

Psychomotor vigilance task

OTHER

Video-polysomnography

OTHER

Sleep and activity monitoring

OTHER

Contacts

Elisa EVANGELISTA

CONTACT

04.66.68.39.00 elisa.evangelista@chu-nimes.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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