Establishment of a Research Cohort on Sleep and Sleep Disorders in Patients With Neurological Diseases
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total sleep time measured by polysomnography
研究概览
简要总结
This study aims to establish a research cohort on sleep and sleep disorders in patients with neurological diseases to systematically evaluate the relationship between various neurological conditions and sleep characteristics or disturbances.
详细描述
The cohort will include patients with confirmed diagnoses such as stroke, Parkinson's disease, epilepsy, cognitive disorders, neuroinfections, and immune-mediated neurological diseases, with collection of demographic data, medical history, and lifestyle factors. All participants will undergo standardized polysomnography (PSG), sleep questionnaires, assessments of cognition, mood, daytime function, as well as relevant imaging and laboratory tests. Designed as a prospective observational study, the cohort will focus on sleep architecture alterations, periodic limb movements, sleep-disordered breathing, REM sleep behavior disorder, nocturnal awakenings, heart rate, and oxygen saturation, and their associations with disease severity and progression. The data will provide a basis for exploring the mechanisms, early indicators, and potential interventions for sleep disturbances in neurological patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of neurological diseases, including but not limited to: Stroke (ischemic or hemorrhagic)，Parkinson's disease and other movement disorders，Epilepsy，Cognitive disorders (mild cognitive impairment or dementia)，Neuroinfections or immune-mediated neurological disorders
- •Ability to complete standardized polysomnography, sleep questionnaires, and assessments of cognition, mood, and daytime function
- •Voluntary participation and provision of written informed consent
排除标准
- •Severe psychiatric disorders or unstable mental status precluding study assessments，Recent (within 3 months) serious infection, surgery, or major medical event
- •Previously diagnosed severe primary sleep disorders (e.g., sleep apnea) under active treatment， -Pregnancy or lactation (if the study involves medication or interventions)
研究组 & 干预措施
patients with neurological diseases
patients with confirmed diagnoses such as stroke, Parkinson's disease, epilepsy, cognitive disorders, neuroinfections, and immune-mediated neurological diseases
干预措施: Symptomatic and Etiological Treatment (Other)
结局指标
主要结局
Total sleep time measured by polysomnography
时间窗: baseline, 3 months and one year
Total sleep time is defined as the total amount of time spent asleep during the overnight polysomnography recording, expressed in minutes.
Wake after sleep onset measured by polysomnography
时间窗: baseline, 3 months and one year
Wake after sleep onset is defined as the total duration of wakefulness after sleep onset and before final awakening during the overnight polysomnography recording, expressed in minutes.
Sleep onset latency measured by polysomnography
时间窗: baseline, 3 months and one year
Sleep onset latency is defined as the time from lights off to the first epoch of sleep during overnight polysomnography.
Number of arousal events measured by polysomnography
时间窗: baseline, 3 months and one year
The number of arousal events is defined as the total number of arousals occurring during the overnight polysomnography recording.
Rapid eye movement sleep onset latency measured by polysomnography
时间窗: baseline, 3 months and one year
Rapid eye movement sleep onset latency is defined as the interval between sleep onset and the first occurrence of rapid eye movement sleep during the overnight polysomnography recording, expressed in minutes.
Non rapid eye movement sleep stage 1, 2, 3, and rapid eye movement sleep time measured by polysomnography
时间窗: baseline, 3 months and one year
Non-rapid eye movement (NREM) sleep stages 1, 2, and 3, and rapid eye movement (REM) sleep time are defined as the total duration spent in each sleep stage during overnight polysomnography, expressed in minutes.
Number of awakenings related to the event measured by polysomnography
时间窗: baseline, 3 months and one year
The number of awakenings related to respiratory events is defined as the total count of awakenings temporally associated with respiratory events during overnight polysomnography.
Number of respiratory events measured by polysomnography
时间窗: baseline, 3 months and one year
The number of respiratory events is defined as the total count of apnea and hypopnea events identified during overnight polysomnography.
Number of decreases in oxygen saturation measured by polysomnography
时间窗: baseline, 3 months and one year
The number of respiratory events is defined as the total count of respiratory events identified during overnight polysomnography.
Sleep period heart rate measured by polysomnography
时间窗: baseline, 3 months and one year
Sleep period heart rate is defined as the average heart rate measured during the sleep period as recorded by overnight polysomnography.
Number of rapid eye movement sleep without atonia measured by polysomnography
时间窗: baseline, 3 months and one year
The number of rapid eye movement sleep without atonia events is defined as the total count of rapid eye movement sleep epochs exhibiting increased muscle activity during overnight polysomnography.
Hypoxic burden measured by polysomnography
时间窗: baseline, 3 months and one year
Hypoxic burden is a quantitative measure of the cumulative severity of nocturnal hypoxemia, calculated from overnight polysomnography. It represents the total area under the curve of oxygen desaturation events, integrating both the depth and duration of oxygen desaturation across the entire sleep period.
次要结局
- The score of Insomnia Severity Index scale(baseline, 3 months and one year)
- The score of 14-item Hamilton anxiety rating scale(baseline, 3 months and one year)
- The score of 17-item Hamilton depression rating scale(baseline, 3 months and one year)
- The score of montreal cognitive assessment scale(baseline, 3 months and one year)
研究者
Zan Wang
Professor，Chief Physician
The First Hospital of Jilin University