Clinical trial NCT04940806: The Value of Combined Detection of Orexin-A, HLA Gene, PSG and MSLT in the Evaluation of Patients With Narcolepsy
Official title: The Value of Combined Detection of Orexin-A, HLA Gene, PSG and MSLT in the Evaluation of Patients With Narcolepsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Narcolepsy
Keywords: Narcolepsy
Orexin
HLA gene
Polysomnography
Multiple sleep latency test
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Pittsburgh sleep quality index scale
timeFrame: 1 day
measure: Epworth Sleeping Scale
timeFrame: 1 day
measure: Insomnia Severity Index
timeFrame: 1 day
measure: Ullanlinna Narcolepsy Scale
timeFrame: 1 day
measure: Stanford Sleepiness Scale
timeFrame: 1 day
measure: Hamilton Anxiety Scale
timeFrame: 1 day
measure: Hamilton Depression Scale
timeFrame: 1 day
measure: Montreal Cognitive Assessment Scale
timeFrame: 1 day
measure: Polysomnography
timeFrame: 2 days
measure: Multiple sleep latency test
timeFrame: 1 day
measure: The level of orexin-A
timeFrame: 1 week
measure: Human leukocyte antigen gene
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
References: