The Value of Combined Detection of Orexin-A, HLA Gene, PSG and MSLT in the Evaluation of Patients With Narcolepsy

NCT ID: NCT04940806

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2025-06-30

Brief Summary

By comparing the differences of orexin-A, HLA gene, PSG, MSLT and other parameters in the evaluation of narcolepsy patients, investigators could find out the relatively high value indicators in the diagnosis of narcolepsy, which is helpful to guide the clinical discovery, diagnosis and treatment of narcolepsy.

Detailed Description

Narcolepsy is a lifelong sleep disorder disease, mainly occurs in the 15~30 year old youth. The incidence rate in different country population is different, which is 0.04% in China. Because of its low incidence rate, and the lack of clinicians' knowledge, it is easy to cause missed diagnosis and misdiagnosis. The decrease of cerebrospinal fluid orexin-A level, positive HLA-DQB1 * 0602 and MSLT all have directive significance for the diagnosis of narcolepsy, but patients with other diseases and healthy people can also show positive indicators. These false positives may lead to wrong judgments. By comparing the differences of orexin-A, HLA gene, PSG, MSLT and other parameters in the evaluation of narcolepsy patients, investigators could find out the relatively high value indicators in the diagnosis of narcolepsy, which is helpful to guide the clinical discovery, diagnosis and treatment of narcolepsy.

Conditions

Narcolepsy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

120 patients with narcolepsy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patients aged 10-70 years old;

2. The symptoms lasted for at least 3 months;

3. With or without cataclysm;

4. MSLT showed that the sleep latency was less than or equal to 8 min, there were two or more times of sleep, the onset of REM sleep;

5. Somnolence can not be explained by other diseases, such as insufficient sleep, OSAHS, delayed sleep phase, drug or drug use, etc.

Exclusion Criteria

1. Somnolence was caused by sleep disorders, central nervous system diseases, brain trauma and other non narcolepsy;

2. Recent lack of sleep or irregular sleep;

3. PSG and MSLT examination can not be diagnosed as narcolepsy;

4. Poor compliance, taking drugs or food and beverage containing central inhibitory components during the trial;

5. Severe neuropsychiatric disorders can not cooperate with the examination;

6. Patients with history of rheumatism, diabetes, ankylosing spondylitis and other HLA related diseases.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lili Cao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Countries

China

Other Identifiers

QianfoshanH H

Identifier Type: -

Identifier Source: org_study_id