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.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Shaanxi
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Xi'an、Shaanxi、中国
- First Affiliated Hospital of PLA Air Force Medical University
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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narcolepsy group and control group
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Whether type 1 narcolepsy is present
時間枠: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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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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