Radar Sleep Monitoring in Type 1 Narcolepsy: Feasibility

NCT07654803 | Active Not Recruiting DMC

• 1 other identifier: KY20262155-F-1
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Narcolepsy Type 1 (NT 1); Hypersomnolence Disorder

Outcome Measures

Primary Outcomes (1)

• Whether type 1 narcolepsy is present

  The entire process, from enrollment to completion of assessments, takes one day.

Study Arms (1)

narcolepsy group and control group

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with sleep disorders

You may qualify if:

• Diagnosed by a doctor with type 1 narcolepsy；
• Can complete two sleep tests: one full night (7 hours in bed) and daytime nap tests the next day (about 10 hours total)；
• Agree to have a small radar device placed near the bed to record sleep alongside the regular tests, and keep it on throughout；
• Medical records are complete and available；
• You (and your parent/guardian if under 18) agree and sign the consent form.

You may not qualify if:

• Not willing to sign the consent form；
• Have irregular sleep hours (e.g., night shifts, recent travel across time zones) or cannot follow the testing schedule to complete all tests；
• Toss and turn too much, get out of bed often, or have too much interference around, causing the radar device to lose signals or record poor-quality data that cannot be analyzed.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

First Affiliated Hospital of PLA Air Force Medical University

Xi'an, Shaanxi, China

Location

Related Publications (2)

• 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.

  PMID: 3809866 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

  RESULT

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)