Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task (IN-DEP)

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depression; Sleep Inertia
• Intervention / Treatment: Other: Psychomotor vigilance task; Other: Video-polysomnography; Other: Sleep and activity monitoring

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Elisa EVANGELISTA; Phone Number: 04.66.68.39.00; Email: elisa.evangelista@chu-nimes.fr

Study Locations

• France
  • Nîmes, France
    • Recruiting
    • CHU de Nîmes
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr
    • Principal Investigator: Elisa EVANGELISTA
    • Sub-Investigator: Beatriz ABRIL
    • Sub-Investigator: Anna Laura RASSU
    • Sub-Investigator: Caroline ALOVISETTI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• The patient is participating in an interventional study
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with sleep inertia and major depression	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.
Patients with major depression without sleep inertia	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.
Controls without mood disorders or sleep inertia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The severity of sleep inertia in patients with major depression and sleep inertia	Measured by Idiopathic Hypersomnia Severity Scale (IHSS). Sleep inertia will be defined as severe in the case of a score ≥ 2 for both items 3 and 4 (frequent and lasting more than 30 min), absent in the case of a score = 0 for both items 3 and 4, and mild in the other cases.	Day 0
Age	Measured in years	Day 0
Sex	Male/female	Day 0
BMI (Body Mass Index)	Kg/m2	Day 0
Age of onset and duration of mood disorder in both patient groups	Years	Day 0
Total sleep time (TTS)	Measured by polysomnography, minutes	Day 0
Sleep efficiency (SE)	Measured by polysomnography, percentage [(total sleep time/time spent in bed) x 100]	Day 0
Sleep onset latency	Measured by polysomnography, minutes	Day 0
Percentage in sleep stage (N1, N2, N3, SP) during the night and in the hour before waking up	Measured by polysomnography, percentage	Day 0
Wake after sleep onset (WASO)	Measured by polysomnography, minutes	Day 0
Microarousal index	Measured by polysomnography, number of microarousals /hour of sleep	Day 0
Apnea-hypopnea index (AHI)	Measured by polysomnography, number of apneas and hypopneas /hour of sleep	Day 0
Index of periodic leg movements (MPJ)	Measured by polysomnography, number of periodic leg movements /hour of sleep	Day 0
Alertness	Karolinska Sleepiness Scale (KSS)	7pm, 7am, 7:30am, 8am and 11am)
Daytime sleepiness	Epworth Sleepiness Scale (ESS)	Day 1
Depressive symptoms	Beck Depression Inventory (BDI-II)	Day 1
Fatigue	Fatigue Severity Scale (FSS)	Day 1
Anxiety and depression	Hospital Anxiety Depression Scale (HADS)	Day 1
Apathy	Apathy Evaluation Scale	Day 1
Insomnia	Insomnia Severity Index (ISI)	Day 1
Morningness-eveningness circadian preferences	Horne and Ostberg Circadian Typology Questionnaire	Day 1
Patient-reported state of health	Visual analog scale (VAS), 0 (worst health imaginable) -100 (best health imaginable)	Day 1
Bedtime and wake-up times (weekdays and weekends)	measured via actimetry and sleep diary over a two-week period two weeks	Week 2
Mean sleep duration (weekdays and weekends)	measured via actimetry and sleep diary over a two-week period two weeks	Week 2
Sleep efficiency (weekdays and weekends)	measured via actimetry and sleep diary over a two-week period two weeks	Week 2
Sleep latency (weekdays and weekends)	measured via actimetry and sleep diary over a two-week period two weeks	Week 2
Wake time after sleep onset	measured via actimetry and sleep diary over a two-week period two weeks	Week 2
Number of nighttime awakenings (weekdays and weekends)	Measured via actimetry and sleep diary over a two-week period	Week 2
Number of naps (weekdays and weekends)	Measured via actimetry and sleep diary over a two-week period	Week 2
Duration of naps (weekdays and weekends)	Measured via actimetry and sleep diary over a two-week period, minutes	Week 2

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Elisa EVANGELISTA, CHU de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: psychomotor vigilance task
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Depressive Disorder; Disorders of Excessive Somnolence; Depressive Disorder, Major; Idiopathic Hypersomnia; Musculoskeletal and Neural Physiological Phenomena; Nervous System Physiological Phenomena; Sleep
• Other Study ID Numbers: NIMAO/2023-2/EE-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No