Actively Recruiting
Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-12-11
110
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has given free and informed consent and signed the consent form
- Patient is a member or beneficiary of a health insurance plan
- Ability to understand, write, and read French
- For depression patients: diagnosis of major depression according to DSM-5
- Suspicion of sleep disorder requiring polysomnographic screening
- Score 1 on IHSS items 3 and 4 for sleep inertia group
- Score = 0 on IHSS items 3 and 4 for group without sleep inertia
- Controls have no complaints of sleep inertia (score = 0 on IHSS items 3 and 4)
- Controls have Epworth Sleepiness Scale score 10
- Controls have Hospital Anxiety Depression Scale score < 8 on items 2, 4, 6, 8, 10, 12, 14
You will not qualify if you...
- Participation in an interventional study
- Under safeguard of justice or state guardianship
- Not free from specified medications (wake-promoting, psychostimulants, neuroleptics, hypnotics, antidepressants, anxiolytics, antiepileptics, dopamine agonists/antagonists, opiates, gabapentin, pregabalin, benzodiazepines, Z-hypnotics, monoamine oxidase inhibitors, catechol-O-methyltransferase inhibitors, sedative antihistamines) for at least 5 half-lives prior to inclusion
- Central nervous system diseases including Parkinson's, mild cognitive impairment, dementia, progressive supranuclear palsy, multisystem atrophy, Huntington's chorea, amyotrophic lateral sclerosis, epilepsy, or history of head trauma with loss of consciousness
- Malignant neoplastic disease requiring treatment in past 12 months
- Other medical or psychiatric illnesses (except depression in the depression group) that could interfere with the study
- History of suicide attempt or suicidal ideation in past month
- Chronic alcohol consumption or drug abuse in past 6 months
- Sleep-wake circadian rhythm disorders or sleep insufficiency per ICSD-3 criteria
- Pregnant, parturient, or breast-feeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU de Nimes
Nîmes, France
Actively Recruiting
Research Team
E
Elisa EVANGELISTA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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