Major DepressionIN-DEPNCT06732284
Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
An observational study of Major Depression and Sleep Inertia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression, Sleep Inertia
- What is being tested?
- Psychomotor vigilance task, Video-polysomnography and Sleep and activity monitoring
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nimes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Elisa EVANGELISTA
About this study
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.
- Conditions
- Major Depression, Sleep Inertia
- Being tested
- Psychomotor vigilance task, Video-polysomnography, Sleep and activity monitoring
- Keywords
- psychomotor vigilance task
- Medical subject headings
- Depressive Disorder, Major, Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Video-polysomnographyOther
Performed overnight as part of routine care (11 p.m. to 7 a.m.).
Sleep and activity monitoringOther
Actimeter and sleep diary to assess the sleep-wake patterns of the participants in their natural environments over a two-week period.
| Study group | Role | What they receive |
|---|---|---|
| Patients with sleep inertia and major depression | Not described Receives: Other: Psychomotor vigilance task; Other: Video-polysomnography; Other: Sleep and activity monitoring | |
| Patients with major depression without sleep inertia | Not described Receives: Other: Psychomotor vigilance task; Other: Video-polysomnography; Other: Sleep and activity monitoring | |
| Controls without mood disorders or sleep inertia | Not described Receives: Other: Psychomotor vigilance task; Other: Video-polysomnography; Other: Sleep and activity monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-sleep at 7pm and the wake-up measurements at 7am, 7:30am, 8am and 11am
Secondary outcomes (30)
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.
Measured: Day 0
Age
Measured in years
Measured: Day 0
Sex
Male/female
Measured: Day 0
BMI (Body Mass Index)
Kg/m2
Measured: Day 0
Age of onset and duration of mood disorder in both patient groups
Years
Measured: Day 0
Total sleep time (TTS)
Measured by polysomnography, minutes
Measured: Day 0
Sleep efficiency (SE)
Measured by polysomnography, percentage [(total sleep time/time spent in bed) x 100]
Measured: Day 0
Sleep onset latency
Measured by polysomnography, minutes
Measured: Day 0
Percentage in sleep stage (N1, N2, N3, SP) during the night and in the hour before waking up
Measured by polysomnography, percentage
Measured: Day 0
Wake after sleep onset (WASO)
Measured by polysomnography, minutes
Measured: Day 0
Microarousal index
Measured by polysomnography, number of microarousals /hour of sleep
Measured: Day 0
Apnea-hypopnea index (AHI)
Measured by polysomnography, number of apneas and hypopneas /hour of sleep
Measured: Day 0
Index of periodic leg movements (MPJ)
Measured by polysomnography, number of periodic leg movements /hour of sleep
Measured: Day 0
Alertness
Karolinska Sleepiness Scale (KSS)
Measured: 7pm, 7am, 7:30am, 8am and 11am)
Daytime sleepiness
Epworth Sleepiness Scale (ESS)
Measured: Day 1
Depressive symptoms
Beck Depression Inventory (BDI-II)
Measured: Day 1
Fatigue
Fatigue Severity Scale (FSS)
Measured: Day 1
Anxiety and depression
Hospital Anxiety Depression Scale (HADS)
Measured: Day 1
Apathy
Apathy Evaluation Scale
Measured: Day 1
Insomnia
Insomnia Severity Index (ISI)
Measured: Day 1
Morningness-eveningness circadian preferences
Horne and Ostberg Circadian Typology Questionnaire
Measured: Day 1
Patient-reported state of health
Visual analog scale (VAS), 0 (worst health imaginable) -100 (best health imaginable)
Measured: Day 1
Bedtime and wake-up times (weekdays and weekends)
measured via actimetry and sleep diary over a two-week period two weeks
Measured: Week 2
Mean sleep duration (weekdays and weekends)
measured via actimetry and sleep diary over a two-week period two weeks
Measured: Week 2
Sleep efficiency (weekdays and weekends)
measured via actimetry and sleep diary over a two-week period two weeks
Measured: Week 2
Sleep latency (weekdays and weekends)
measured via actimetry and sleep diary over a two-week period two weeks
Measured: Week 2
Wake time after sleep onset
measured via actimetry and sleep diary over a two-week period two weeks
Measured: Week 2
Number of nighttime awakenings (weekdays and weekends)
Measured via actimetry and sleep diary over a two-week period
Measured: Week 2
Number of naps (weekdays and weekends)
Measured via actimetry and sleep diary over a two-week period
Measured: Week 2
Duration of naps (weekdays and weekends)
Measured via actimetry and sleep diary over a two-week period, minutes
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start4 Nov 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa EVANGELISTA, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732284
- Sponsor's protocol ID
- NIMAO/2023-2/EE-01
- Acronym
- IN-DEP
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
- ClinicalTrials.gov ID
- NCT06732284
- Acronym / sponsor ID
- IN-DEP / NIMAO/2023-2/EE-01
- Conditions
- Major Depression, Sleep Inertia
- Keywords
- psychomotor vigilance task
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with sleep inertia and major depression | – | Other: Psychomotor vigilance task, Other: Video-polysomnography, Other: Sleep and activity monitoring |
| Patients with major depression without sleep inertia | – | Other: Psychomotor vigilance task, Other: Video-polysomnography, Other: Sleep and activity monitoring |
| Controls without mood disorders or sleep inertia | – | Other: Psychomotor vigilance task, Other: Video-polysomnography, Other: Sleep and activity monitoring |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychomotor vigilance taskFive 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 | Controls without mood disorders or sleep inertia, Patients with major depression without sleep inertia, Patients with sleep inertia and major depression |
| Video-polysomnographyPerformed overnight as part of routine care (11 p.m. to 7 a.m.). | Other | Controls without mood disorders or sleep inertia, Patients with major depression without sleep inertia, Patients with sleep inertia and major depression |
| Sleep and activity monitoringActimeter and sleep diary to assess the sleep-wake patterns of the participants in their natural environments over a two-week period. | Other | Controls without mood disorders or sleep inertia, Patients with major depression without sleep inertia, Patients with sleep inertia and major depression |
Primary outcome
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.
30 secondary outcomes
The severity of sleep inertia in patients with major depression and sleep inertia
Time frame: Day 0
Age
Time frame: Day 0
Sex
Time frame: Day 0
BMI (Body Mass Index)
Time frame: Day 0
Age of onset and duration of mood disorder in both patient groups
Time frame: Day 0
Total sleep time (TTS)
Time frame: Day 0
Sleep efficiency (SE)
Time frame: Day 0
Sleep onset latency
Time frame: Day 0
Percentage in sleep stage (N1, N2, N3, SP) during the night and in the hour before waking up
Time frame: Day 0
Wake after sleep onset (WASO)
Time frame: Day 0
Microarousal index
Time frame: Day 0
Apnea-hypopnea index (AHI)
Time frame: Day 0
Index of periodic leg movements (MPJ)
Time frame: Day 0
Alertness
Time frame: 7pm, 7am, 7:30am, 8am and 11am)
Daytime sleepiness
Time frame: Day 1
Depressive symptoms
Time frame: Day 1
Fatigue
Time frame: Day 1
Anxiety and depression
Time frame: Day 1
Apathy
Time frame: Day 1
Insomnia
Time frame: Day 1
Morningness-eveningness circadian preferences
Time frame: Day 1
Patient-reported state of health
Time frame: Day 1
Bedtime and wake-up times (weekdays and weekends)
Time frame: Week 2
Mean sleep duration (weekdays and weekends)
Time frame: Week 2
Sleep efficiency (weekdays and weekends)
Time frame: Week 2
Sleep latency (weekdays and weekends)
Time frame: Week 2
Wake time after sleep onset
Time frame: Week 2
Number of nighttime awakenings (weekdays and weekends)
Time frame: Week 2
Number of naps (weekdays and weekends)
Time frame: Week 2
Duration of naps (weekdays and weekends)
Time frame: Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisa EVANGELISTA principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression and Sleep Inertia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa EVANGELISTA (04.66.68.39.00, elisa.evangelista@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.