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Development of a Diagnostic Model for Narcolepsy Based on Eye-Tracking Technology

Development of a Diagnostic Model for Narcolepsy Based on Eye-Tracking Technology

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119686
Enrollment
Unknown
Registered
2026-03-02
Start date
2026-03-09
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

central disorders of hypersomnolence

Interventions

Type 1 Narcolepsygroup:None
Healthy control group:None
Idiopathic Hypersomnia group:None
Type 2 Narcolepsy group:None

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. All study participants must meet the diagnostic criteria for Type 1 Narcolepsy (NT1), Type 2 Narcolepsy (NT2), and Idiopathic Hypersomnia (IH) as defined in the International Classification of Sleep Disorders, 3rd Edition, Revised (ICSD-3-R) published by the American Academy of Sleep Medicine (AASM). 2. Aged 12 to 60 years; 3. Score no less than 10 points on the Epworth Sleepiness Scale (ESS); 4. Able to cooperate with data collection required for the study and sign the paper-based informed consent form. Healthy control group: 1. Age and gender matched with the subjects in the NT1 group. 2. No self-reported complaints of sleep disorders. 3. Score lower than 10 points on the Epworth Sleepiness Scale (ESS). 4. Able to cooperate with data collection required for the study and sign the paper-based informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of diseases that may interfere with excessive daytime sleepiness, such as chronic sleep deprivation and untreated moderate-to-severe obstructive sleep apnea. 2. Presence of retinal dysfunction, color vision abnormalities, or neurological disorders that affect light transmission. 3. Presence of ocular diseases, including cataracts, artificial eyes, and strabismus. 4. Presence of drug/substance abuse disorders. 5. Presence of mental illnesses such as suicidal ideation. 6. Current use of medications that affect rapid eye movement (REM) sleep, e.g., anti-anxiety and antidepressant drugs. 7. Use of medications that impact alertness (e.g., modafinil, methylphenidate) within 5 half-lives prior to enrollment. 8. History of transmeridian travel or shift work within the past month.

Design outcomes

Primary

MeasureTime frame
Psychomotor Vigilance Task performance metrics;Sustained Attention Response Test performance metrics;Light test performance indicators;Evaluation indices of the simulated driving task;Epworth Sleepiness Scale;Multiple Sleep Latency Test;

Countries

China

Contacts

Public ContactHuan Yu

Huashan Hospital, Fudan University

dr.yuhuan@163.com+86 21 54602179

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026