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

NCT06732284 | Recruiting

• 1 other identifier: NIMAO/2023-2/EE-01
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

psychomotor vigilance task

Outcome Measures

Primary Outcomes (1)

• Level of vigilance and sustained attention before and after sleep between groups

  Change in the number of omissions in the PVT test. An omission is defined as a reaction time (RT) ≥ 500 msec.

  Pre-sleep at 7pm and the wake-up measurements at 7am, 7:30am, 8am and 11am

Secondary Outcomes (30)

• The severity of sleep inertia in patients with major depression and sleep inertia

  Day 0

• Age

  Day 0

• Sex

  Day 0

• BMI (Body Mass Index)

  Day 0

• Age of onset and duration of mood disorder in both patient groups

  Day 0

Study Arms (3)

Patients with sleep inertia and major depression

Other: Psychomotor vigilance task; Other: Video-polysomnography; Other: Sleep and activity monitoring

Patients with major depression without sleep inertia

Other: Psychomotor vigilance task; Other: Video-polysomnography; Other: Sleep and activity monitoring

Controls without mood disorders or sleep inertia

Other: Psychomotor vigilance task; Other: Video-polysomnography; Other: Sleep and activity monitoring

Interventions

Psychomotor vigilance task OTHER

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.

Controls without mood disorders or sleep inertia; Patients with major depression without sleep inertia; Patients with sleep inertia and major depression

Video-polysomnography OTHER

Performed overnight as part of routine care (11 p.m. to 7 a.m.).

Controls without mood disorders or sleep inertia; Patients with major depression without sleep inertia; Patients with sleep inertia and major depression

Sleep and activity monitoring OTHER

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; Patients with major depression without sleep inertia; Patients with sleep inertia and major depression

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises three groups of 30 analyzable participants: patients with Major Depressive Disorder and sleep inertia, patients with Major Depressive Disorder and 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.

You may qualify if:

• 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
• 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).

You may not qualify if:

• The patient is participating in an interventional study
• The patient is under safeguard of justice or state guardianship
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Idiopathic Hypersomnia

Interventions

Sleep

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elisa EVANGELISTA

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa EVANGELISTA

CONTACT

04.66.68.39.00; elisa.evangelista@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 13, 2024
• Study Start: November 4, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

FR (1)