Clinical trial NCT05443373: A Multi-Signal Based Monitoring System for CNS Hypersomnias
Official title: A Multi-Signal Based Monitoring System for CNS Hypersomnias : A 10-year Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypersomnia
Keywords: Sleep
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 600
Sex: ALL
Minimum age (years): 9
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 9-45 years old subjects with narcolepsy , Kleine-Levin syndrome or Idiopathic Hypersomnia

Brief summary: 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.

Detailed description: 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:

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.

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.

Data analysis method:

Use multiple physiological signals to generate real-time quantitative algorithms and find physiological biomarkers related to hypersomnias. Use the aforementioned data were categorized and grouped through data analysis based on computer machine learning, neural network, and other algorithms. Then the investigators will build a predictive model based on the results and write a medical report and publish it.

Eligibility criteria: Inclusion Criteria:

1. Patients with narcolepsy , Kleine-Levin syndrome(KLS) or Idiopathic Hypersomnia (IH) diagnosed by a physician who meet the ICSD-3 diagnostic criteria
2. Age: 9-45 years old
3. Those who agree to participate in this research and can sign the consent form.

Exclusion Criteria:

1. Patients with epilepsy, head trauma and severe organic brain disease.
2. Patients with severe Obstructive Sleep Apnea (OSA) and severe Periodic Limb Movement Disorder (PLMD) who have not received treatment.
3. People with narcolepsy due to other physical and brain diseases.
4. Those who cannot cooperate with the brain imaging examination and neurocognitive function test.
5. Exclude those who have had brain surgery for brain tumor hemangioma, or those who have cerebral blood vessel metal clips.
6. Exclude current pacemakers.
7. Excluded those who had implanted artificial heart metal valve.
8. Those who underwent surgery within the last 3 months were excluded.
9. rule out claustrophobia
10. Those who are unwilling to participate in this research or are unwilling to fill in the consent form.

Primary outcomes:
measure: Polysomnography (PSG)
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Multiple sleep latency test (MSLT)
timeFrame: Once a year until the study is completed (up to 3 years)
measure: HLA TYPING
timeFrame: baseline
measure: Actigraphy
timeFrame: Once a year until the study is completed (up to 3 years)
measure: PET/MRI
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Conners' Continuous Performance Test (CPT)
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Epworth Sleepoiness Scale (ESS)
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Pediatric Daytime Sleepiness Scale (PDSS)
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Short Form-36 (SF-36)
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Polysomnography (PSG)-SE
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Polysomnography (PSG)-TST
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Polysomnography (PSG)-WASO
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Polysomnography (PSG)-REM
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Polysomnography (PSG)-SWS
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Actigraphy-TST
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Actigraphy-SE
timeFrame: Once a year until the study is completed (up to 3 years)
measure: Actigraphy-WASO
timeFrame: Once a year until the study is completed (up to 3 years)
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Principal Investigator
name: Yu-Shu Huang, PhD
role: STUDY_DIRECTOR
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