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This study aims to evaluate the clinical feasibility of a millimeter-wave radar sleep monitoring system in the diagnosis of Narcolepsy Type 1 (NT1). Narcolepsy is a chronic central nervous system sleep disorder characterized by excessive daytime sleepiness as its core symptom. NT1 is defined by the presence of cataplexy or reduced cerebrospinal fluid hypocretin-1 (Hcrt-1) levels. The current diagnostic gold standard relies on overnight polysomnography (PSG) and the Multiple Sleep Latency Test (MSLT); however, conventional methods are limited by complex operation, time-consuming procedures, high patient compliance demands, and poor scalability in primary care settings.
This prospective, single-center, concurrent validation study plans to enroll 40 clinically diagnosed NT1 patients. Participants will undergo simultaneous PSG/MSLT and millimeter-wave radar sleep monitoring. Using PSG/MSLT as the gold standard, we will assess the consistency and accuracy of the radar system in identifying core parameters, including mean sleep latency (MSL), sleep-onset rapid eye movement period (SOREMP) count, and sleep architecture, while also evaluating data integrity and patient compliance.
Key collected indicators include: demographic characteristics, clinical symptoms, Hcrt-1 levels, HLA genotyping, PSG parameters (total sleep time [TST], sleep efficiency [SE], sleep latency [SL], REM latency, SOREMP, sleep stage proportions, apnea-hypopnea index [AHI], periodic limb movement index [PLMI]), MSLT parameters (MSL, SOREMP count), and radar system parameters (TST, SL, SE, arousal frequency, etc.). Statistical analysis will be performed using SPSS 23.0. Normally distributed continuous variables will be analyzed using independent samples t-tests, non-normally distributed data using Mann-Whitney U tests, and categorical variables using chi-square tests.
The study duration is 7 months (May to December 2026). This research may provide a non-contact, convenient, and cost-effective alternative or supplementary monitoring approach for narcolepsy, promoting the application of outpatient and home-based sleep monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| narcolepsy group and control group |
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| Measure | Description | Time Frame |
|---|---|---|
| Whether type 1 narcolepsy is present | The entire process, from enrollment to completion of assessments, takes one day. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with sleep disorders
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of PLA Air Force Medical University | Xi'an | Shaanxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3809866 | Result | Carskadon MA, Dement WC, Mitler MM, Roth T, Westbrook PR, Keenan S. Guidelines for the multiple sleep latency test (MSLT): a standard measure of sleepiness. Sleep. 1986 Dec;9(4):519-24. doi: 10.1093/sleep/9.4.519. No abstract available. | |
| Result | [1] American Academy of Sleep Medicine. International classification of sleep disorders-third edition (ICSD-3)[M]. Darien IL: American Academy of Sleep Medicine, 2014 |
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Involves participant privacy and personally sensitive information, and is subject to data protection regulations.
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| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| D001523 |
| Mental Disorders |