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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Shaanxi
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Xi'an, Shaanxi, 중국
- First Affiliated Hospital of PLA Air Force Medical University
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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narcolepsy group and control group
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Whether type 1 narcolepsy is present
기간: The entire process, from enrollment to completion of assessments, takes one day.
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The entire process, from enrollment to completion of assessments, takes one day.
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- 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
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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