Health TrialsbyHealthPanel

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

ConditionsMajor DepressionSleep Inertia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-54
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Psychomotor vigilance task

    Other intervention

    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 intervention

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

  • Sleep and activity monitoring

    Other intervention

    Actimeter and sleep diary to assess the sleep-wake patterns of the participants in their natural environments over a two-week period.

Treatment groups

110 Participants
are divided into 3 treatment groups
Group A: Patients with sleep inertia and major depression3 interventions
Group B: Patients with major depression without sleep inertia3 interventions
Group C: Controls without mood disorders or sleep inertia3 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

Age

Measured in years

Time frame
Day 0
3

Sex

Male/female

Time frame
Day 0
4

BMI (Body Mass Index)

Kg/m2

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Nīmes

Lead sponsor

Source ClinicalTrials.gov
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