NCT06732284招募中不适用
Study of Sleep Inertia in Major Depressive Disorder by the Psychomotor Vigilance Task
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年11月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Level of vigilance and sustained attention before and after sleep between groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Level of vigilance and sustained attention before and after sleep between groups
时间窗: 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.
次要结局
- The severity of sleep inertia in patients with major depression and sleep inertia(Day 0)
- Age(Day 0)
- Sex(Day 0)
- BMI (Body Mass Index)(Day 0)
- Age of onset and duration of mood disorder in both patient groups(Day 0)
- Total sleep time (TTS)(Day 0)
- Sleep efficiency (SE)(Day 0)
- Sleep onset latency(Day 0)
- Percentage in sleep stage (N1, N2, N3, SP) during the night and in the hour before waking up(Day 0)
- Daytime sleepiness(Day 1)
- Index of periodic leg movements (MPJ)(Day 0)
- Alertness(7pm, 7am, 7:30am, 8am and 11am))
- Wake after sleep onset (WASO)(Day 0)
- Microarousal index(Day 0)
- Apnea-hypopnea index (AHI)(Day 0)
- Depressive symptoms(Day 1)
- Fatigue(Day 1)
- Anxiety and depression(Day 1)
- Apathy(Day 1)
- Insomnia(Day 1)
- Morningness-eveningness circadian preferences(Day 1)
- Patient-reported state of health(Day 1)
- Bedtime and wake-up times (weekdays and weekends)(Week 2)
- Mean sleep duration (weekdays and weekends)(Week 2)
- Sleep efficiency (weekdays and weekends)(Week 2)
- Sleep latency (weekdays and weekends)(Week 2)
- Wake time after sleep onset(Week 2)
- Number of nighttime awakenings (weekdays and weekends)(Week 2)
- Number of naps (weekdays and weekends)(Week 2)
- Duration of naps (weekdays and weekends)(Week 2)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Effect of Partial Sleep Deprivation on Cognition and Cytokines in Individuals With Major DepressionMajor DepressionNCT00291239Zentrum für Integrative Psychiatrie40
已完成
不适用
Cognitive Behavioral Therapy for Treatment of Insomnia in Patients With Major DepressionInsomniaNCT02678702University of Aarhus47
Unknown
不适用
Night in Japan Home Sleep Monitoring StudySleep Initiation and Maintenance DisordersDepressionNCT03276585Shiga University2,000
招募中
不适用
A cohort study on ICU sleep and deliriumMental and behavioural disordersKCT0007851Dong-A University300
招募中
不适用
Stimulating Brain Waves During Deep SleepPlaceboExperimentalNCT05024578University of Ottawa110