Sleep inertia in major depressive disorder measured with the psychomotor vigilance task
Official title: Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
Run by Centre Hospitalier Universitaire de Nīmes · NCT06732284 · Data updated 2026-11-12
This study will test whether overnight sleep recordings and a simple vigilance task can reveal sleep inertia in people with major depression compared with depressed people without sleep inertia and with non-depressed controls.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 54 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 1 site (Nîmes) |
| Status | Recruiting |
| Started | November 4, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | December 11, 2025 |
| Trial ID | NCT06732284 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who can give informed consent, are covered by a health insurance plan, speak French, and meet DSM-5 criteria for major depressive disorder who are being referred for polysomnographic screening—separated into those who report sleep inertia and those who do not.
✕Probably not a fit
People with clinically significant sleep apnea or periodic limb movements on polysomnography, those with total sleep time under six hours, patients unable to stop interfering medications, or those currently enrolled in interventional trials are unlikely to gain direct benefit from this observational protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will enroll three groups of 30 participants: patients with major depressive disorder (MDD) who report sleep inertia, patients with MDD who do not report sleep inertia, and non-depressed control patients referred for polysomnography. All participants will complete video-polysomnography, sleep and activity monitoring, and repeated psychomotor vigilance task (PVT) sessions to measure morning vigilance and sleep-related performance. Controls will only be analyzed if their polysomnography shows low apnea-hypopnea and periodic limb movement indices and at least six hours of total sleep time. Comparative analysis will link PVT performance and sleep architecture to the presence or absence of reported sleep inertia in MDD.
Why it matters
Potential benefit: If successful, this work could help clinicians identify objective signs of sleep inertia in people with depression and guide better timing or targeting of treatments and daily activities.
How similar studies have gone: The psychomotor vigilance task is a well-established tool for measuring sleepiness and vigilance, but its targeted use to characterize sleep inertia specifically in major depressive disorder is relatively novel and has limited prior data.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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CHU de Nimes
Nîmes, France Recruiting
Study contacts
- Principal investigator: Elisa EVANGELISTA — CHU de Nimes
- Study coordinator: Elisa EVANGELISTA
- Email: elisa.evangelista@chu-nimes.fr
- Phone: 04.66.68.39.00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.