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

NCT04940806 | Unknown

• 1 other identifier: QianfoshanH H
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Narcolepsy

Keywords

Narcolepsy; Orexin; HLA gene; Polysomnography; Multiple sleep latency test

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Montreal Cognitive Assessment Scale

  A full score of 30 points, and ≥ 26 points were considered as normal cognition.

  1 day

• 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

• 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

• 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

• 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

Study Arms (1)

120 patients with narcolepsy

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants of the study were patients who were admitted to the sleep center of Qianfoshan Hospital of Shandong Province from August 2019 to June 2025. All patients had clinical symptoms of narcolepsy and were diagnosed as narcolepsy by auxiliary laboratory examination.

You may qualify if:

• Patients aged 10-70 years old;
• The symptoms lasted for at least 3 months;
• With or without cataclysm;
• 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;
• Somnolence can not be explained by other diseases, such as insufficient sleep, OSAHS, delayed sleep phase, drug or drug use, etc.

You may not qualify if:

• Somnolence was caused by sleep disorders, central nervous system diseases, brain trauma and other non narcolepsy;
• Recent lack of sleep or irregular sleep;
• PSG and MSLT examination can not be diagnosed as narcolepsy;
• Poor compliance, taking drugs or food and beverage containing central inhibitory components during the trial;
• Severe neuropsychiatric disorders can not cooperate with the examination;
• Patients with history of rheumatism, diabetes, ankylosing spondylitis and other HLA related diseases.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 28, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)