An observational study in Narcolepsy, sponsored by Qianfoshan Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 10 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-28.
Sponsored by Qianfoshan Hospital · Observational
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.
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.
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's planned enrollment of 120 is below the median of 135 across 38 observational studies indexed under Narcolepsy.
Browse Narcolepsy studies →Qianfoshan Hospital is the lead sponsor of 144 studies on the registry; 75 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day
Montreal Cognitive Assessment Scale
A full score of 30 points, and ≥ 26 points were considered as normal cognition.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week
Plan to share: No
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