Radar Sleep Monitoring in Type 1 Narcolepsy: Feasibility

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Narcolepsy Type 1 (NT 1) Disorders of Excessive Somnolence Dyssomnias Hypersomnolence Disorder Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of PLA Air Force Medical University

Xi'an, Shaanxi, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Whether type 1 narcolepsy is present

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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Jun 17, 2026
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting