Clinical trial NCT06732284: Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
Official title: Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Major Depression
Sleep Inertia
Keywords: psychomotor vigilance task
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Level of vigilance and sustained attention before and after sleep between groups
timeFrame: Pre-sleep at 7pm and the wake-up measurements at 7am, 7:30am, 8am and 11am
Secondary outcomes:
measure: The severity of sleep inertia in patients with major depression and sleep inertia
timeFrame: Day 0
measure: Age
timeFrame: Day 0
measure: Sex
timeFrame: Day 0
measure: BMI (Body Mass Index)
timeFrame: Day 0
measure: Age of onset and duration of mood disorder in both patient groups
timeFrame: Day 0
measure: Total sleep time (TTS)
timeFrame: Day 0
measure: Sleep efficiency (SE)
timeFrame: Day 0
measure: Sleep onset latency
timeFrame: Day 0
measure: Percentage in sleep stage (N1, N2, N3, SP) during the night and in the hour before waking up
timeFrame: Day 0
measure: Wake after sleep onset (WASO)
timeFrame: Day 0
measure: Microarousal index
timeFrame: Day 0
measure: Apnea-hypopnea index (AHI)
timeFrame: Day 0
measure: Index of periodic leg movements (MPJ)
timeFrame: Day 0
measure: Alertness
timeFrame: 7pm, 7am, 7:30am, 8am and 11am)
measure: Daytime sleepiness
timeFrame: Day 1
measure: Depressive symptoms
timeFrame: Day 1
measure: Fatigue
timeFrame: Day 1
measure: Anxiety and depression
timeFrame: Day 1
measure: Apathy
timeFrame: Day 1
measure: Insomnia
timeFrame: Day 1
measure: Morningness-eveningness circadian preferences
timeFrame: Day 1
measure: Patient-reported state of health
timeFrame: Day 1
measure: Bedtime and wake-up times (weekdays and weekends)
timeFrame: Week 2
measure: Mean sleep duration (weekdays and weekends)
timeFrame: Week 2
measure: Sleep efficiency (weekdays and weekends)
timeFrame: Week 2
measure: Sleep latency (weekdays and weekends)
timeFrame: Week 2
measure: Wake time after sleep onset
timeFrame: Week 2
measure: Number of nighttime awakenings (weekdays and weekends)
timeFrame: Week 2
measure: Number of naps (weekdays and weekends)
timeFrame: Week 2
measure: Duration of naps (weekdays and weekends)
timeFrame: Week 2
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU de Nimes
name: Elisa EVANGELISTA
role: PRINCIPAL_INVESTIGATOR
References: