Radar Sleep Monitoring in Type 1 Narcolepsy: Feasibility

Feasibility Study of a Millimeter-Wave Radar Sleep Monitoring System in Patients With Type 1 Narcolepsy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypersomnolence Disorder; Narcolepsy Type 1 (NT 1)

• Study Type: Observational
• Enrollment (Estimated): 1

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • First Affiliated Hospital of PLA Air Force Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with sleep disorders

Description

Inclusion Criteria:

• (1) Patients clinically diagnosed with type 1 narcolepsy; (2) Agree to undergo overnight polysomnography (PSG) and the subsequent daytime multiple sleep latency test (MSLT), with monitoring duration meeting the PSG/MSLT scoring requirements (PSG recording duration ≥ 7 hours, total MSLT procedure duration ≥ 10 hours); (3) Simultaneous data collection using a millimeter-wave radar sleep monitoring system during the monitoring period, with complete and uninterrupted signal acquisition; (4) Complete clinical data available; (5) Willing to participate in this study and sign the informed consent form (if the participant is under 18 years of age, both the participant's assent and the written informed consent of the legal guardian are required).

Exclusion Criteria:

• (1) Refusal to sign the informed consent form; (2) Inability to complete the full protocol of overnight PSG and the subsequent daytime MSLT due to irregular sleep-wake schedules (e.g., shift work, travel across time zones) or poor compliance; (3) Loss of raw data or poor signal quality during millimeter-wave radar signal acquisition caused by substantial body movements, getting out of bed, environmental interference, or other factors, making effective analysis impossible.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
narcolepsy group and control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Whether type 1 narcolepsy is present	The entire process, from enrollment to completion of assessments, takes one day.

Collaborators and Investigators

• Sponsor: Xijing Hospital

Publications and helpful links

General Publications

• 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.
• [1] American Academy of Sleep Medicine. International classification of sleep disorders-third edition (ICSD-3)[M]. Darien IL: American Academy of Sleep Medicine, 2014

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Disorders of Excessive Somnolence
• Other Study ID Numbers: KY20262155-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Involves participant privacy and personally sensitive information, and is subject to data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No