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

Not yet recruiting

• Conditions: Major Depression; Sleep Inertia

• Registration Number: NCT06732284
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-13
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Study Start: 2025-03
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of vigilance and sustained attention before and after sleep between groups	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 Outcome Measures

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

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nîmes, France