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NCT06732284Recruiting

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

Source: ClinicalTrials.gov · Last updated 11 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
110 (estimated)
First submitted
9 Dec 2024
Start date
4 Nov 2025
Primary completion date
Mar 2027
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Diseases
Depression
NCT number
NCT06732284

What you commit to

  • Study type: Observational
  • Planned participants: 110
  • From 4 Nov 2025 to the primary completion date, Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with a malignant neoplastic disease requiring therapeutic treatment in the 12months prior to the screening visit
  • Chronic alcohol consumption or drug abuse in the previous 6 months

Other illness

  • 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.
  • 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
  • Sleep-wake circadian rhythm disorders and presence of sleep insufficiency according to ICSD-3 criteria

Lab values

  • 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.

Other

  • The patient is participating in an interventional study
  • The patient is under safeguard of justice or state guardianship
  • Pregnant, parturient or breast-feeding women.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 54 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Nîmes
Coordinator of this site? Confirm its status
NîmesFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.