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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with sleep inertia and major depression |
| ||
| Patients with major depression without sleep inertia |
| ||
| Controls without mood disorders or sleep inertia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychomotor vigilance task | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-sleep at 7pm and the wake-up measurements at 7am, 7:30am, 8am and 11am |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 |
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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
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:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa EVANGELISTA | Contact | 04.66.68.39.00 | elisa.evangelista@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Elisa EVANGELISTA | CHU de Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nimes | Recruiting | Nîmes | France |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D020177 | Idiopathic Hypersomnia |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D006970 | Disorders of Excessive Somnolence |
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| ID | Term |
|---|---|
| D012890 | Sleep |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Video-polysomnography | Other | Performed overnight as part of routine care (11 p.m. to 7 a.m.). |
|
| Sleep and activity monitoring | Other | Actimeter and sleep diary to assess the sleep-wake patterns of the participants in their natural environments over a two-week period. |
|
| Age | Measured in years | Day 0 |
| Sex | Male/female | Day 0 |
| BMI (Body Mass Index) | Kg/m2 | Day 0 |
| Age of onset and duration of mood disorder in both patient groups | Years | Day 0 |
| Total sleep time (TTS) | Measured by polysomnography, minutes | Day 0 |
| Sleep efficiency (SE) | Measured by polysomnography, percentage [(total sleep time/time spent in bed) x 100] | Day 0 |
| Sleep onset latency | Measured by polysomnography, minutes | Day 0 |
| Percentage in sleep stage (N1, N2, N3, SP) during the night and in the hour before waking up | Measured by polysomnography, percentage | Day 0 |
| Wake after sleep onset (WASO) | Measured by polysomnography, minutes | Day 0 |
| Microarousal index | Measured by polysomnography, number of microarousals /hour of sleep | Day 0 |
| Apnea-hypopnea index (AHI) | Measured by polysomnography, number of apneas and hypopneas /hour of sleep | Day 0 |
| Index of periodic leg movements (MPJ) | Measured by polysomnography, number of periodic leg movements /hour of sleep | Day 0 |
| Alertness | Karolinska Sleepiness Scale (KSS) | 7pm, 7am, 7:30am, 8am and 11am) |
| Daytime sleepiness | Epworth Sleepiness Scale (ESS) | Day 1 |
| Depressive symptoms | Beck Depression Inventory (BDI-II) | Day 1 |
| Fatigue | Fatigue Severity Scale (FSS) | Day 1 |
| Anxiety and depression | Hospital Anxiety Depression Scale (HADS) | Day 1 |
| Apathy | Apathy Evaluation Scale | Day 1 |
| Insomnia | Insomnia Severity Index (ISI) | Day 1 |
| Morningness-eveningness circadian preferences | Horne and Ostberg Circadian Typology Questionnaire | Day 1 |
| Patient-reported state of health | Visual analog scale (VAS), 0 (worst health imaginable) -100 (best health imaginable) | Day 1 |
| Bedtime and wake-up times (weekdays and weekends) | measured via actimetry and sleep diary over a two-week period two weeks | Week 2 |
| Mean sleep duration (weekdays and weekends) | measured via actimetry and sleep diary over a two-week period two weeks | Week 2 |
| Sleep efficiency (weekdays and weekends) | measured via actimetry and sleep diary over a two-week period two weeks | Week 2 |
| Sleep latency (weekdays and weekends) | measured via actimetry and sleep diary over a two-week period two weeks | Week 2 |
| Wake time after sleep onset | measured via actimetry and sleep diary over a two-week period two weeks | Week 2 |
| Number of nighttime awakenings (weekdays and weekends) | Measured via actimetry and sleep diary over a two-week period | Week 2 |
| Number of naps (weekdays and weekends) | Measured via actimetry and sleep diary over a two-week period | Week 2 |
| Duration of naps (weekdays and weekends) | Measured via actimetry and sleep diary over a two-week period, minutes | Week 2 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |