NarcolepsyNCT06279247
Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
An observational study of Narcolepsy, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 26 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with narcolepsy
Who may be able to join
- All patients met the diagnostic criteria of the International Classification of Sleep Disorders, Third edition (ICSD-3).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Wenjing Jiang, 18560082210, jiangwenjing@qiluhospital.com
About this study
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.
Read the detailed description
- Study design The baseline proteomics and metabolomics analysis of body fluid of narcolepsy (type 1 and type 2) and healthy volunteers, and the proteomics and metabolomics analysis of body fluid of narcolepsy patients after drug treatment were performed, and the differential metabolites and differential protein spots that could be used as potential molecular markers of narcolepsy were found by cross-sectional study.
- Study subjects Source of study subjects: inpatients/healthy volunteers (Study subjects were well matched in gender, age, physical condition, etc.).
- Study variables (factors) and measurements 3.1 Data collected from all subjects included: medical record information (basic information, scale score, sleep data, imaging examination) (10KB/ sample), body fluid (blood (3ml/ case)/urine (3ml/ case)/stool (2g/ case)/cerebrospinal fluid (3ml/ case) collected 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).
Baseline proteomic and metabolomics assays were performed. Proteomics and metabolomics of body fluid in narcolepsy patients after drug treatment. (Sample collection requires metabolomics sampling in the same season and time period) 3.2 Assessment of sleepiness
- Sleepiness assessment: Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI)
- Diagnostic evaluation of sleepiness: sleep apnea monitoring (PSG) and multiple sleep latency test (MSLT) were completed. Overnight polysomnography (PSG) can provide detailed physiological sleep information and multiple sleep latency test (MSLT) can objectively measure sleepiness. The multiple Sleep latency testing experiment (MSLT) was performed the day after an overnight PSG recording that showed ≥ 6 hours of adequate sleep at night and could effectively explain the MSLT data. The MSLT was based on 20-min PSG recordings that were repeated every 2 h, 4-5 times per day, starting approximately 2 h after morning awakening. Individuals were asked to attempt to fall asleep at each time point. The ICSD-3 states that in order to diagnose narcolepsy, the mean sleep latency of MSLT should be 8 minutes or less and more than two sleep-onset rapid eye movement periods (SOREMPs).
Study outcomes
- 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.
- To study the body fluid and imaging characteristics of narcolepsy patients. 5. Data collection and management Data collection was performed using a paper case report form, and subject information (basic information, scale scores, sleep data, imaging examination) was entered into a computer by someone. Baseline proteomics and metabolomics of body fluid (blood/urine/stool/cerebrospinal fluid) in patients with narcolepsy (type 1 and type 2) and body fluid (blood/urine/stool) in healthy volunteers. Proteomics and metabolomics of body fluid in narcolepsy patients after drug treatment. Statistical analysis was performed by a clinical statistician.
- Conditions
- Narcolepsy
- Keywords
- Narcolepsy, metabonomics, proteomics
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| narcolepsy group | Not described | |
| health control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To screen potential molecular markers related to the biological characteristics and prognosis of narcolepsy.
- 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.
- To study the body fluid and imaging characteristics of narcolepsy patients.
Measured: 2022.09~2024.09
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Sep 2022
- Primary completion26 Aug 2026 (estimated)
- Study completion26 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279247
- Sponsor's protocol ID
- KYLL-202212-011
- Status last verified
- Dec 2025
- First submitted
- 19 Feb 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
- ClinicalTrials.gov ID
- NCT06279247
- Acronym / sponsor ID
- KYLL-202212-011
- Conditions
- Narcolepsy
- Keywords
- Narcolepsy, metabonomics, proteomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 26 Aug 2026 (estimated)
- Study completion
- 26 Aug 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Study design The baseline proteomics and metabolomics analysis of body fluid of narcolepsy (type 1 and type 2) and healthy volunteers, and the proteomics and metabolomics analysis of body fluid of narcolepsy patients after drug treatment were performed, and the differential metabolites and differential protein spots that could be used as potential molecular markers of narcolepsy were found by cross-sectional study.
- Study subjects Source of study subjects: inpatients/healthy volunteers (Study subjects were well matched in gender, age, physical condition, etc.).
- Study variables (factors) and measurements 3.1 Data collected from all subjects included: medical record information (basic information, scale score, sleep data, imaging examination) (10KB/ sample), body fluid (blood (3ml/ case)/urine (3ml/ case)/stool (2g/ case)/cerebrospinal fluid (3ml/ case) collected 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).
Baseline proteomic and metabolomics assays were performed. Proteomics and metabolomics of body fluid in narcolepsy patients after drug treatment. (Sample collection requires metabolomics sampling in the same season and time period) 3.2 Assessment of sleepiness
- Sleepiness assessment: Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI)
- Diagnostic evaluation of sleepiness: sleep apnea monitoring (PSG) and multiple sleep latency test (MSLT) were completed. Overnight polysomnography (PSG) can provide detailed physiological sleep information and multiple sleep latency test (MSLT) can objectively measure sleepiness. The multiple Sleep latency testing experiment (MSLT) was performed the day after an overnight PSG recording that showed ≥ 6 hours of adequate sleep at night and could effectively explain the MSLT data. The MSLT was based on 20-min PSG recordings that were repeated every 2 h, 4-5 times per day, starting approximately 2 h after morning awakening. Individuals were asked to attempt to fall asleep at each time point. The ICSD-3 states that in order to diagnose narcolepsy, the mean sleep latency of MSLT should be 8 minutes or less and more than two sleep-onset rapid eye movement periods (SOREMPs).
Study outcomes
- 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.
- To study the body fluid and imaging characteristics of narcolepsy patients. 5. Data collection and management Data collection was performed using a paper case report form, and subject information (basic information, scale scores, sleep data, imaging examination) was entered into a computer by someone. Baseline proteomics and metabolomics of body fluid (blood/urine/stool/cerebrospinal fluid) in patients with narcolepsy (type 1 and type 2) and body fluid (blood/urine/stool) in healthy volunteers. Proteomics and metabolomics of body fluid in narcolepsy patients after drug treatment. Statistical analysis was performed by a clinical statistician.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| narcolepsy group | – | – |
| health control group | – | – |
Who may qualify
- Ages
- 5 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with narcolepsy
Key inclusion criteria (1 listed)
- All patients met the diagnostic criteria of the International Classification of Sleep Disorders, Third edition (ICSD-3).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To screen potential molecular markers related to the biological characteristics and prognosis of narcolepsy.
Time frame: 2022.09~2024.09
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact haiyun li (18560088921, haiyunli1122@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To screen potential molecular markers related to the biological characteristics and prognosis of narcolepsy. (time frame: 2022.09~2024.09). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.