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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 54
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
France
CHU de Nimes
RECRUITING
Nîmes
Contact Information
Primary
Elisa EVANGELISTA
elisa.evangelista@chu-nimes.fr
04.66.68.39.00
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2027-03
Participants
Target number of participants: 110
Treatments
Patients with sleep inertia and major depression
Patients with major depression without sleep inertia
Controls without mood disorders or sleep inertia
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nīmes

This content was sourced from clinicaltrials.gov