Actively Recruiting
Proteomics and Metabolomics Analysis of Body Fluid in Patients With Narcolepsy
Led by Qilu Hospital of Shandong University · Updated on 2026-03-24
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Narcolepsy is a rare chronic disorder affecting the central nervous system, commonly seen in children and adolescents but less so in adults. It is characterized by excessive daytime sleepiness, sudden muscle weakness (cataplexy), sleep paralysis, and hallucinations during sleep. Symptoms may also include increased appetite, weight gain, fragmented sleep, anxiety, and depression. Due to its varied symptoms, narcolepsy is often misdiagnosed. This research aims to explore changes in body fluid proteins and metabolites in narcolepsy patients to better understand the disease's underlying causes. The study involves comparing proteomics and metabolomics profiles of body fluids, including blood, urine, stool, and cerebrospinal fluid, from narcolepsy patients and healthy volunteers. Samples from narcolepsy patients will be analyzed both before and after drug treatment to identify potential molecular markers. Healthy volunteers will provide blood, urine, and stool samples but not cerebrospinal fluid. Samples will be collected in the same season and time period to ensure consistency. Participants will undergo detailed data collection, including medical history, sleep assessments using scales like the Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index, and diagnostic sleep tests such as overnight polysomnography and multiple sleep latency tests. These evaluations help confirm diagnosis and measure sleepiness objectively. Researchers will analyze the molecular data alongside clinical information to identify markers related to narcolepsy's biological features and prognosis. The study is expected to continue until 2027, with data carefully managed and statistically analyzed throughout.
CONDITIONS
Brief Title
Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must meet the diagnostic criteria of the International Classification of Sleep Disorders, Third edition (ICSD-3).
You will not qualify if you...
- Presence of primary hypersomnia or hypersomnia due to shift work, sleep deprivation, or other sleep rhythm disturbances.
- Excessive sleep caused by drug abuse.
- Diagnosis of Parkinson's disease, Alzheimer's disease, other nervous system diseases, or mental illnesses.
- Having serious heart, lung, liver, kidney, blood, endocrine diseases, or recent acute or chronic infections.
- Use of sedatives, hypnotics, antidepressants, lithium, or dopamine receptor antagonists within two weeks before examination.
- Inability to cooperate with polysomnography (PSG) and multiple sleep latency test (MSLT) due to various reasons.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to assess eligibility including sleep disorder diagnosis and clinical history
Duration - 2 to 3 days
Participants undergo diagnostic assessments including overnight polysomnography (PSG) and multiple sleep latency test (MSLT) to evaluate sleepiness and sleep characteristics.
1 overnight visit for PSG and 1 daytime visit for MSLT the following day
Duration - Up to 2 years
Participants provide body fluid samples and complete sleepiness and sleep quality assessments to support proteomics and metabolomics analysis.
Periodic sample collections aligned with treatment timing and seasonal requirements, approximately 2 to 3 visits per year
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
H
haiyun li
W
wenjing jiang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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