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Study to uncover morning fog in depression

NCT ID NCT06732284

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at sleep inertia—the grogginess and poor attention right after waking—in people with major depression. Researchers will test reaction times and monitor sleep in 110 participants, including depressed patients with and without sleep inertia, plus healthy controls. The goal is to better understand how depression affects morning alertness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better understand and identify sleep inertia in depression, potentially leading to improved management strategies.
What could go wrong
This is an observational study, not a treatment trial. It is small (110 participants) and early-stage, so findings may not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 54 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Nimes

    RECRUITING

    Nîmes, France

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