Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy

March 13, 2024 updated by: Qilu Hospital of Shandong University

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

  1. 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.
  2. Study subjects Source of study subjects: inpatients/healthy volunteers (Study subjects were well matched in gender, age, physical condition, etc.).
  3. 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

  1. Sleepiness assessment: Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI)
  2. 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

  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. 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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with narcolepsy

Description

Inclusion Criteria

  • All patients met the diagnostic criteria of the International Classification of Sleep Disorders, Third edition (ICSD-3).

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
health control group
narcolepsy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2022.09~2024.09

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202212-011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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