Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task (IN-DEP)

December 4, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nîmes, France
        • Recruiting
        • CHU de Nîmes
        • Contact:
        • Principal Investigator:
          • Elisa EVANGELISTA
        • Sub-Investigator:
          • Beatriz ABRIL
        • Sub-Investigator:
          • Anna Laura RASSU
        • Sub-Investigator:
          • Caroline ALOVISETTI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with sleep inertia and major depression
Other: Psychomotor vigilance task
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.
Other: Video-polysomnography
Performed overnight as part of routine care (11 p.m. to 7 a.m.).
Other: Sleep and activity monitoring
Actimeter and sleep diary to assess the sleep-wake patterns of the participants in their natural environments over a two-week period.
Patients with major depression without sleep inertia
Other: Psychomotor vigilance task
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.
Other: Video-polysomnography
Performed overnight as part of routine care (11 p.m. to 7 a.m.).
Other: Sleep and activity monitoring
Actimeter and sleep diary to assess the sleep-wake patterns of the participants in their natural environments over a two-week period.
Controls without mood disorders or sleep inertia
Other: Psychomotor vigilance task
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.
Other: Video-polysomnography
Performed overnight as part of routine care (11 p.m. to 7 a.m.).
Other: Sleep and activity monitoring
Actimeter and sleep diary to assess the sleep-wake patterns of the participants in their natural environments over a two-week period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Level of vigilance and sustained attention before and after sleep between groups
Time Frame: 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.
Pre-sleep at 7pm and the wake-up measurements at 7am, 7:30am, 8am and 11am

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The severity of sleep inertia in patients with major depression and sleep inertia
Time Frame: 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.
Day 0
Age
Time Frame: Day 0
Measured in years
Day 0
Sex
Time Frame: Day 0
Male/female
Day 0
BMI (Body Mass Index)
Time Frame: Day 0
Kg/m2
Day 0
Age of onset and duration of mood disorder in both patient groups
Time Frame: Day 0
Years
Day 0
Total sleep time (TTS)
Time Frame: Day 0
Measured by polysomnography, minutes
Day 0
Sleep efficiency (SE)
Time Frame: Day 0
Measured by polysomnography, percentage [(total sleep time/time spent in bed) x 100]
Day 0
Sleep onset latency
Time Frame: Day 0
Measured by polysomnography, minutes
Day 0
Percentage in sleep stage (N1, N2, N3, SP) during the night and in the hour before waking up
Time Frame: Day 0
Measured by polysomnography, percentage
Day 0
Wake after sleep onset (WASO)
Time Frame: Day 0
Measured by polysomnography, minutes
Day 0
Microarousal index
Time Frame: Day 0
Measured by polysomnography, number of microarousals /hour of sleep
Day 0
Apnea-hypopnea index (AHI)
Time Frame: Day 0
Measured by polysomnography, number of apneas and hypopneas /hour of sleep
Day 0
Index of periodic leg movements (MPJ)
Time Frame: Day 0
Measured by polysomnography, number of periodic leg movements /hour of sleep
Day 0
Alertness
Time Frame: 7pm, 7am, 7:30am, 8am and 11am)
Karolinska Sleepiness Scale (KSS)
7pm, 7am, 7:30am, 8am and 11am)
Daytime sleepiness
Time Frame: Day 1
Epworth Sleepiness Scale (ESS)
Day 1
Depressive symptoms
Time Frame: Day 1
Beck Depression Inventory (BDI-II)
Day 1
Fatigue
Time Frame: Day 1
Fatigue Severity Scale (FSS)
Day 1
Anxiety and depression
Time Frame: Day 1
Hospital Anxiety Depression Scale (HADS)
Day 1
Apathy
Time Frame: Day 1
Apathy Evaluation Scale
Day 1
Insomnia
Time Frame: Day 1
Insomnia Severity Index (ISI)
Day 1
Morningness-eveningness circadian preferences
Time Frame: Day 1
Horne and Ostberg Circadian Typology Questionnaire
Day 1
Patient-reported state of health
Time Frame: Day 1
Visual analog scale (VAS), 0 (worst health imaginable) -100 (best health imaginable)
Day 1
Bedtime and wake-up times (weekdays and weekends)
Time Frame: Week 2
measured via actimetry and sleep diary over a two-week period two weeks
Week 2
Mean sleep duration (weekdays and weekends)
Time Frame: Week 2
measured via actimetry and sleep diary over a two-week period two weeks
Week 2
Sleep efficiency (weekdays and weekends)
Time Frame: Week 2
measured via actimetry and sleep diary over a two-week period two weeks
Week 2
Sleep latency (weekdays and weekends)
Time Frame: Week 2
measured via actimetry and sleep diary over a two-week period two weeks
Week 2
Wake time after sleep onset
Time Frame: Week 2
measured via actimetry and sleep diary over a two-week period two weeks
Week 2
Number of nighttime awakenings (weekdays and weekends)
Time Frame: Week 2
Measured via actimetry and sleep diary over a two-week period
Week 2
Number of naps (weekdays and weekends)
Time Frame: Week 2
Measured via actimetry and sleep diary over a two-week period
Week 2
Duration of naps (weekdays and weekends)
Time Frame: Week 2
Measured via actimetry and sleep diary over a two-week period, minutes
Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elisa EVANGELISTA, CHU de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIMAO/2023-2/EE-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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