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

Narcolepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04940806
• Other study ID #: QianfoshanH H
• Status: Enrolling by invitation
• Start date: May 1, 2021
• Est. completion date: June 2025

Study information

• Verified date: June 2021
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: June 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Narcolepsy

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh sleep quality index scale	The sleep quality of the patients in the past month was evaluated. The higher the score, the worse the sleep quality. The scale of the score is 0-21, and the higher score means a worse outcome.	1 day
Primary	Epworth Sleeping Scale	Assess the possibility of dozing (not just feeling tired) in recent months. The higher the score was, the more likely it was to doze during the day. The scale of the score is 0-24, and the higher score means a worse outcome.	1 day
Primary	Insomnia Severity Index	Liker scale is used to evaluate the nature and symptoms of sleep disorders. The higher the score, the more serious the insomnia. The scale of the score is 0-28, and the higher score means a worse outcome.	1 day
Primary	Ullanlinna Narcolepsy Scale	It can be effectively distributed as a control group for sleeping sickness and healthy people. The total score is between 0-44. The higher the score is, the higher the possibility of narcolepsy is. The scale of the score is 0-44, and the higher score means a worse outcome.	1 day
Primary	Stanford Sleepiness Scale	Subjective assessment tool to assess sleepiness. The scale of the score is 0-7, and the higher score means a worse outcome.	1 day
Primary	Hamilton Anxiety Scale	It can be used to evaluate the depressive symptoms of depression, manic depression, neurosis and other diseases. The higher the score, the more anxiety.; It can be used to evaluate the depressive symptoms of depression, manic depression, neurosis and other diseases. The higher the score, the more anxiety.; It can be used to evaluate the depressive symptoms of depression, manic depression, neurosis and other diseases. The higher the score, the more anxiety.; It can be used to evaluate the depressive symptoms of depression, manic depression, neurosis and other diseases. The higher the score, the more anxiety.; It can be used to evaluate the depressive symptoms of depression, manic depression, neurosis and other diseases. The higher the score, the more anxiety.; The scale of the score is 0-56, and the higher score means a worse outcome.	1 day
Primary	Hamilton Depression Scale	It can be used to evaluate the depressive symptoms of depression, manic depression, neurosis and other diseases. The higher the score, the more severe the depression. The scale of the score is 0-96, and the higher score means a worse outcome.	1 day
Primary	Montreal Cognitive Assessment Scale	A full score of 30 points, and = 26 points were considered as normal cognition.	1 day
Primary	Polysomnography	The participants completed PSG in the sleep room from 10:00 p.m. to 6:00 a.m. the next day. The test lasted for at least 7 hours to ensure that the participants had enough sleep before MSLT. Professional and technical personnel interpreted the results and calculated the PSG sleep latency, REM latency, soremps sleep, sleep efficiency, AHI and the proportion of each sleep period.	2 days
Primary	Multiple sleep latency test	Participants completed MSLT in the sleep room, according to the standard method published by the American Sleep Society, 20 minutes each time, a total of 5 times.Professional and technical personnel interpreted the results and calculated the MSLT MSL, soremps sleep; In MSLT, MSL = 8 min and soremps = 2 were positive.	1 day
Primary	The level of orexin-A	The qualified clinician performed lumbar puncture on the participants, extracted cerebrospinal fluid and sub packed it into EP tube. The samples that could not be detected immediately were stored at - 80 ? for detection (about half a year for detection). The level of orexin-A in cerebrospinal fluid was detected by enzyme-linked immunosorbent assay (ELISA). CSF orexin-A concentration is either = 110 pg/mL or <1/3 of mean values obtained in normal human with the same standardized assay.	1 week
Primary	Human leukocyte antigen gene	After blood sampling, HLA gene was detected by sequence specific primer gene amplification. Most ofl patients with cataplexy are positive for DQB1*0602, which is a HLA subtype.	1 week