A Multi-Signal Based Monitoring System for CNS Hypersomnias : A 10-year Longitudinal Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- HLA TYPING
研究概览
简要总结
This is a retrospective and prospective cohort study. There are 600 subjects (age 9-45) will be collected.The purposes of this study are as follows:(1) The main purpose is to use Multi-Signal Based Monitoring System to link with brain image data and perform cross-comparison to find out possible pathological mechanisms of these CNS hypersomnias.(2) Use the Multi-Signal Based Monitoring System to link with brain image data and perform cross-comparison to further screen out these clinically significant biomarkers for CNS hypersomnias, and to find ideal and accurate physiological biomarkers that can monitor the course of the disease.(3) Utilize these precisely monitored biomarkers to track changes in the biomarkers and the long-term course of these CNS hypersomnias, and evaluate the treatment effect and prognosis.(4) Use computer machine learning and other algorithms to analyze and construct a variety of faster and more accurate prediction models for these CNS hypersomnias, thereby achieving the goal of preventive medicine.
详细描述
Excessive daytime sleepiness (EDS) is a common symptom in the general population. The prevalence ranges from 5% to 30%. And daytime drowsiness often brings negative effects, and even the daily function and the quality of life is impaired due to these hypersomnias. In some severe cases, many accidents can occur and endanger life. The current third edition of the International Classification of Sleep Disorders (ICSD 3) specifically classified "Central nervous system disorders of hypersomnolence" as Narcolepsy type 1 and type 2 ; idiopathic hypersomnia(IH), and Kleine-Levin syndrome (KLS). However, so far, except for Narcolepsy type 1, which has a relatively clear pathological mechanism that is related to the reduced secretion of hypocretin, other hypersomnia disorders such as Narcolepsy type 2, IH and KLS, that is no clear neurophysiological diagnosis standard, and the mechanism of these diseases is still not clear. Therefore, the diagnosis can only rely on the clinical symptoms and the clinical experience physicians. That is why the diagnosis of these diseases still has great difficulties and challenges. Therefore, in order to make the diagnosis more accurate, the investigators have to find out the "Biologic and neurophysiologic biomarkers" for these diseases. And let patients receive the correct treatment quickly.
The purposes of this study are as follows:
- The main purpose is to use Multi-Signal Based Monitoring System to link with brain image data and perform cross-comparison to find out possible pathological mechanisms of these CNS hypersomnias.
- Use the Multi-Signal Based Monitoring System to link with brain image data and perform cross-comparison to further screen out these clinically significant biomarkers for CNS hypersomnias, and to find ideal and accurate physiological biomarkers that can monitor the course of the disease.
- Utilize these precisely monitored biomarkers to track changes in the biomarkers and the long-term course of these CNS hypersomnias, and evaluate the treatment effect and prognosis.
- Use computer machine learning and other algorithms to analyze and construct a variety of faster and more accurate prediction models for these CNS hypersomnias, thereby achieving the goal of preventive medicine.
Research method:
This is a retrospective and prospective cohort study. There are 600 subjects (age 9-45) will be collected. These subjects will be divided into the five groups: (1) experimental group (narcolepsy Type 1, 300 subjects); (2) experimental group (narcolepsy Type 2, 100 subjects); and (3) experimental group (KLS, 100 subjects); and (4) experimental group (IH,50 subjects); and (5) healthy control group (age and gender matched healthy subjects,50 subjects). The investigators will collect all the clinical data for each subject, including clinical characteristics, sleep examination data, actigraphy, HLA typing, and brain imaging data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 9 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with narcolepsy , Kleine-Levin syndrome(KLS) or Idiopathic Hypersomnia (IH) diagnosed by a physician who meet the ICSD-3 diagnostic criteria
- •Age: 9-45 years old
- •Those who agree to participate in this research and can sign the consent form.
排除标准
- •Patients with epilepsy, head trauma and severe organic brain disease.
- •Patients with severe Obstructive Sleep Apnea (OSA) and severe Periodic Limb Movement Disorder (PLMD) who have not received treatment.
- •People with narcolepsy due to other physical and brain diseases.
- •Those who cannot cooperate with the brain imaging examination and neurocognitive function test.
- •Exclude those who have had brain surgery for brain tumor hemangioma, or those who have cerebral blood vessel metal clips.
- •Exclude current pacemakers.
- •Excluded those who had implanted artificial heart metal valve.
- •Those who underwent surgery within the last 3 months were excluded.
- •rule out claustrophobia
- •Those who are unwilling to participate in this research or are unwilling to fill in the consent form.
结局指标
主要结局
HLA TYPING
时间窗: baseline
The investigators will use sequence-specific primer - polymerase chain reaction (SSP-PCR) to detect HLA-DQB1 and reverse sequence-specific oligonucleotide probes (SSOPs) to detect HLA-DQA1,and also use Sequencing Based Typing (SBT) and reverse sequence specific oligonucleotide (rSSO) to detect HLA-DRB and HLA-DQB in the lab.
PET/MRI
时间窗: through study completion, an average of 1 year
Positron Emission Tomography is a fusion of PET and MRI imaging techniques that can show the spread of diseased cells in soft tissue. The PET/MRI system can scan various parts of the patient and collect PET and MRI images separately for early diagnosis.
Polysomnography (PSG)
时间窗: Once a year until the study is completed (up to 3 years)
Change in sleep latency (SL, mins) based on PSG during the study.
Multiple sleep latency test (MSLT)
时间窗: Once a year until the study is completed (up to 3 years)
Change in Change in sleep latency (SL, mins) based on MSLT during the study.
Actigraphy
时间窗: Once a year until the study is completed (up to 3 years)
Change in sleep latency (mins) based on actigraphy during the study.
次要结局
- Polysomnography (PSG)-SE(Once a year until the study is completed (up to 3 years))
- Polysomnography (PSG)-TST(Once a year until the study is completed (up to 3 years))
- Polysomnography (PSG)-SWS(Once a year until the study is completed (up to 3 years))
- Conners' Continuous Performance Test (CPT)(Once a year until the study is completed (up to 3 years))
- Wisconsin Card Sorting Test (WCST)(Once a year until the study is completed (up to 3 years))
- Polysomnography (PSG)-REM(Once a year until the study is completed (up to 3 years))
- Actigraphy-SE(Once a year until the study is completed (up to 3 years))
- Epworth Sleepoiness Scale (ESS)(Once a year until the study is completed (up to 3 years))
- Pediatric Daytime Sleepiness Scale (PDSS)(Once a year until the study is completed (up to 3 years))
- Short Form-36 (SF-36)(Once a year until the study is completed (up to 3 years))
- Polysomnography (PSG)-WASO(Once a year until the study is completed (up to 3 years))
- Actigraphy-TST(Once a year until the study is completed (up to 3 years))
- Actigraphy-WASO(Once a year until the study is completed (up to 3 years))