NCT06732284

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

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.

Conditions

• Major Depression
• Sleep Inertia

Interventions

Type	Name	Description
OTHER	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.
OTHER	Video-polysomnography	Performed overnight as part of routine care (11 p.m. to 7 a.m.).
OTHER	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.

Timeline

• Start date: 2025-11-04
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-12-13
• Last updated: 2025-12-11

Locations

1 site across 1 country: France