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Radar Sleep Monitoring in Type 1 Narcolepsy: Feasibility

NCT07654803 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2026-07-21

No results posted yet for this study

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

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-07
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07654803 on ClinicalTrials.gov