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NCT Number: NCT06732284

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

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.

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Key information

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, France

Location status: Recruiting

Location contact

Anissa Megzari

CONTACT

[email protected]

04.66.68.42.36

Anna Laura RASSU

SUB_INVESTIGATOR

Beatriz ABRIL

SUB_INVESTIGATOR

Caroline ALOVISETTI

SUB_INVESTIGATOR

Elisa EVANGELISTA

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Video-polysomnography

Other

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

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.

Primary outcomes

  1. Level of vigilance and sustained attention before and after sleep between groups

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

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

Secondary outcomes

  1. The severity of sleep inertia in patients with major depression and sleep inertia

    Time frame: Day 0

    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.

  2. Age

    Time frame: Day 0

    Measured in years

  3. Sex

    Time frame: Day 0

    Male/female

  4. BMI (Body Mass Index)

    Time frame: Day 0

    Kg/m2

  5. Age of onset and duration of mood disorder in both patient groups

    Time frame: Day 0

    Years

  6. Total sleep time (TTS)

    Time frame: Day 0

    Measured by polysomnography, minutes

  7. Sleep efficiency (SE)

    Time frame: Day 0

    Measured by polysomnography, percentage [(total sleep time/time spent in bed) x 100]

  8. Sleep onset latency

    Time frame: Day 0

    Measured by polysomnography, minutes

  9. Percentage in sleep stage (N1, N2, N3, SP) during the night and in the hour before waking up

    Time frame: Day 0

    Measured by polysomnography, percentage

  10. Wake after sleep onset (WASO)

    Time frame: Day 0

    Measured by polysomnography, minutes

  11. Microarousal index

    Time frame: Day 0

    Measured by polysomnography, number of microarousals /hour of sleep

  12. Apnea-hypopnea index (AHI)

    Time frame: Day 0

    Measured by polysomnography, number of apneas and hypopneas /hour of sleep

  13. Index of periodic leg movements (MPJ)

    Time frame: Day 0

    Measured by polysomnography, number of periodic leg movements /hour of sleep

  14. Alertness

    Time frame: 7pm, 7am, 7:30am, 8am and 11am)

    Karolinska Sleepiness Scale (KSS)

  15. Daytime sleepiness

    Time frame: Day 1

    Epworth Sleepiness Scale (ESS)

  16. Depressive symptoms

    Time frame: Day 1

    Beck Depression Inventory (BDI-II)

  17. Fatigue

    Time frame: Day 1

    Fatigue Severity Scale (FSS)

  18. Anxiety and depression

    Time frame: Day 1

    Hospital Anxiety Depression Scale (HADS)

  19. Apathy

    Time frame: Day 1

    Apathy Evaluation Scale

  20. Insomnia

    Time frame: Day 1

    Insomnia Severity Index (ISI)

  21. Morningness-eveningness circadian preferences

    Time frame: Day 1

    Horne and Ostberg Circadian Typology Questionnaire

  22. Patient-reported state of health

    Time frame: Day 1

    Visual analog scale (VAS), 0 (worst health imaginable) -100 (best health imaginable)

  23. Bedtime and wake-up times (weekdays and weekends)

    Time frame: Week 2

    measured via actimetry and sleep diary over a two-week period two weeks

  24. Mean sleep duration (weekdays and weekends)

    Time frame: Week 2

    measured via actimetry and sleep diary over a two-week period two weeks

  25. Sleep efficiency (weekdays and weekends)

    Time frame: Week 2

    measured via actimetry and sleep diary over a two-week period two weeks

  26. Sleep latency (weekdays and weekends)

    Time frame: Week 2

    measured via actimetry and sleep diary over a two-week period two weeks

  27. Wake time after sleep onset

    Time frame: Week 2

    measured via actimetry and sleep diary over a two-week period two weeks

  28. Number of nighttime awakenings (weekdays and weekends)

    Time frame: Week 2

    Measured via actimetry and sleep diary over a two-week period

  29. Number of naps (weekdays and weekends)

    Time frame: Week 2

    Measured via actimetry and sleep diary over a two-week period

  30. Duration of naps (weekdays and weekends)

    Time frame: Week 2

    Measured via actimetry and sleep diary over a two-week period, minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa EVANGELISTA

CONTACT

[email protected]

04.66.68.39.00

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: IN-DEP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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