Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
1 other identifier
observational
60
1 country
1
Brief Summary
Narcolepsy (NRL) is a rare chronic central nervous system dysfunction disease, which is more common in children and adolescents, and less common in adults. Its typical clinical features include excessive daytime sleep, paroxysmal cataplexy, sleep paralysis and sleep hallucination. In addition to the above typical manifestations, patients with narcolepsy can also manifest as hyperappetite, weight gain, multiple dreams, sleep fragmentation, anxiety and depression and other emotional disorders. In particular, in narcolepsy type 1 with cataplexy, cataplexy episodes can be confused with falls caused by seizures, transient ischemic attacks or neuromuscular disorders, or even mental conversion disorders. Due to its diverse clinical symptoms, it is easy to be missed and misdiagnosed. At present, the pathogenesis of narcolepsy is still unclear, and its pathogenesis may be related to immune, genetic, environmental, infection, central nervous system degeneration and other factors. This study aims to investigate the changes of body fluid proteomics and metabolomics in patients with narcolepsy, and to provide an important basis for the pathogenesis of narcolepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 26, 2027
March 24, 2026
December 1, 2025
4 years
February 19, 2024
March 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To screen potential molecular markers related to the biological characteristics and prognosis of narcolepsy.
1. omics analysis of metabolic mechanisms related to narcolepsy and screening of co-enriched pathways. To screen potential molecular markers related to the biological characteristics and prognosis of narcolepsy. 2. To study the body fluid and imaging characteristics of narcolepsy patients.
2022.09~2024.09
Study Arms (2)
narcolepsy group
health control group
Eligibility Criteria
Patients with narcolepsy
You may qualify if:
- All patients met the diagnostic criteria of the International Classification of Sleep Disorders, Third edition (ICSD-3).
You may not qualify if:
- primary hypersomnia or hypersomnia due to shift work, sleep deprivation and other sleep rhythm disturbances;
- excessive sleep due to drug abuse;
- suffering from Parkinson's disease, Alzheimer's disease and other nervous system diseases and mental diseases;
- complicated with heart, lung, liver, kidney, blood endocrine system and other basic diseases, or acute chronic infection in a short period of time;
- Use of sedatives, hypnotics, antidepressants, lithium and dopamine receptor antagonists for two weeks before examination;
- patients who cannot cooperate with PSG and MSLT due to various factors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Biospecimen
Information of subjects' medical records (basic information, scale score, sleep data, imaging examination) (10KB/ sample), collection of body fluid (blood (3ml/ case)/urine (3ml/ case)/stool (2g/ case)/cerebrospinal fluid (3ml/ case) from narcolepsy patients) Basic information (10KB/ sample), body fluids (blood (3ml/ case)/urine (3ml/ case)/stool (2g/ case)) of healthy subjects were collected (cerebrospinal fluid was not collected from healthy subjects).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2024
First Posted
February 28, 2024
Study Start
September 1, 2022
Primary Completion (Estimated)
August 26, 2026
Study Completion (Estimated)
August 26, 2027
Last Updated
March 24, 2026
Record last verified: 2025-12