Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
NCT ID: NCT06732284
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
110 participants
OBSERVATIONAL
2025-11-04
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with sleep inertia and major depression
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.
Video-polysomnography
Performed overnight as part of routine care (11 p.m. to 7 a.m.).
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.
Patients with major depression without sleep inertia
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.
Video-polysomnography
Performed overnight as part of routine care (11 p.m. to 7 a.m.).
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.
Controls without mood disorders or sleep inertia
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.
Video-polysomnography
Performed overnight as part of routine care (11 p.m. to 7 a.m.).
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.
Interventions
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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.
Video-polysomnography
Performed overnight as part of routine care (11 p.m. to 7 a.m.).
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
54 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Elisa EVANGELISTA
Role: PRINCIPAL_INVESTIGATOR
CHU de Nimes
Locations
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CHU de Nimes
Nîmes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NIMAO/2023-2/EE-01
Identifier Type: -
Identifier Source: org_study_id
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