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

Centre Hospitalier Universitaire de Nīmes110 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

110

Conditions

Major Depression Sleep Inertia

Interventions

Psychomotor vigilance taskOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 54 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: Day 0

Age

Measured in years

Time frame: Day 0

Sex

Male/female

Time frame: Day 0

BMI (Body Mass Index)

Kg/m2

Time frame: Day 0

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

Years

Time frame: Day 0

Total sleep time (TTS)

Measured by polysomnography, minutes

Time frame: Day 0

Sleep efficiency (SE)

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

Time frame: Day 0

Sleep onset latency

Measured by polysomnography, minutes

Time frame: Day 0

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

Measured by polysomnography, percentage

Time frame: Day 0

Wake after sleep onset (WASO)

Measured by polysomnography, minutes

Time frame: Day 0

Microarousal index

Measured by polysomnography, number of microarousals /hour of sleep

Time frame: Day 0

Apnea-hypopnea index (AHI)

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

Time frame: Day 0

Index of periodic leg movements (MPJ)

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

Time frame: Day 0

Alertness

Karolinska Sleepiness Scale (KSS)

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

Daytime sleepiness

Epworth Sleepiness Scale (ESS)

Time frame: Day 1

Depressive symptoms

Beck Depression Inventory (BDI-II)

Time frame: Day 1

Fatigue

Fatigue Severity Scale (FSS)

Time frame: Day 1

Anxiety and depression

Hospital Anxiety Depression Scale (HADS)

Time frame: Day 1

Apathy

Apathy Evaluation Scale

Time frame: Day 1

Insomnia

Insomnia Severity Index (ISI)

Time frame: Day 1

Morningness-eveningness circadian preferences

Horne and Ostberg Circadian Typology Questionnaire

Time frame: Day 1

Patient-reported state of health

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

Time frame: Day 1

Bedtime and wake-up times (weekdays and weekends)