UnknownNot Applicable

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

China120 participantsStarted 2021-05-01

Plain-language 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.

Who can participate

Age range10 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Pittsburgh sleep quality index scale

Timeframe: 1 day

Epworth Sleeping Scale

Timeframe: 1 day

Insomnia Severity Index

Timeframe: 1 day

Ullanlinna Narcolepsy Scale

Timeframe: 1 day

Stanford Sleepiness Scale

Timeframe: 1 day

Hamilton Anxiety Scale

Timeframe: 1 day

Hamilton Depression Scale

Timeframe: 1 day

Montreal Cognitive Assessment Scale

Timeframe: 1 day

Polysomnography

Timeframe: 2 days

Trial details

NCT IDNCT04940806

SponsorQianfoshan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05

View on ClinicalTrials.gov More Narcolepsy trials

Plain-language summary

Who can participate

Age range10 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Pittsburgh sleep quality index scale

Timeframe: 1 day

Epworth Sleeping Scale

Timeframe: 1 day

Insomnia Severity Index

Timeframe: 1 day

Ullanlinna Narcolepsy Scale

Timeframe: 1 day

Stanford Sleepiness Scale

Timeframe: 1 day

Hamilton Anxiety Scale

Timeframe: 1 day

Hamilton Depression Scale

Timeframe: 1 day

Montreal Cognitive Assessment Scale

Timeframe: 1 day

Polysomnography

Timeframe: 2 days