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临床试验/NCT07084701
NCT07084701招募中不适用

Effects of Non-Invasive Superficial Craniocervical Lymphatic Drainage (NSCLD) on Memory and Cognitive Function in Adults With Sleep Deprivation: A Proof-of-Concept Study

Tao Liu1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Digit Span Test

研究概览

简要总结

This Effects of Non-Invasive Superficial Craniocervical Lymphatic Drainage (NSCLD) on Memory and Cognitive Function in Adults with Sleep deprivation: A Proof-of-Concept Study aims to investigate the effects of Non-Invasive Superficial Craniocervical Lymphatic Drainage (NSCLD) on memory and cognitive function in adults experiencing sleep deprivation(SD). Given the known impact of SD on cognitive performance, this study seeks to explore whether NSCLD, as a non-invasive intervention, can mitigate the cognitive impairments associated with SD.

详细描述

Sleep deprivation (SD) is widespread in modern society, particularly among medical students, residents, and individuals in high-stress occupations. Numerous studies have demonstrated that acute sleep deprivation significantly impairs cognitive processes such as attention, working memory, and executive function. Even short-term cognitive impairment can have serious consequences, including impaired judgment, slowed reaction times, and increased error rates.

Currently, interventions targeting cognitive decline following sleep deprivation are limited. Common strategies primarily include medications (such as caffeine and modafinil) and restorative sleep. However, these methods have limitations in both clinical and real-life settings: on one hand, medications may lead to tolerance and side effects, and on the other hand, restorative sleep often cannot reverse cognitive impairment in the short term. Therefore, developing a safe, convenient, and rapidly effective non-pharmacological intervention is of great significance.

In recent years, the glymphatic system has garnered increasing attention. This system is believed to play a key role in clearing metabolic waste from the brain, regulating sleep structure, and maintaining neurocognitive function. Superficial craniocervical lymphatic drainage (SCLD) has been proposed as a potential mechanism to improve cognitive function by enhancing the flow of cerebrospinal fluid (CSF) and lymph, reducing neuroinflammation, and minimizing the accumulation of metabolic waste.

In June 2025, a study published in Nature provided the first in vivo evidence supporting this hypothesis. Researchers applied non-invasive mechanical stimulation to the superficial lymphatic system on the skin surface of the mouse neck, resulting in a doubling of CSF drainage efficiency to cervical lymph nodes and correction of impaired brain-lymphatic efflux function in aged mice. These findings provide direct mechanistic support for the potential application of non-invasive SCLD intervention in humans.

Therefore, this study aims to establish an acute sleep deprivation model in healthy adults and explore the immediate effects of NSCLD intervention on cognitive function, with the goal of providing preliminary clinical evidence for non-pharmacological intervention strategies related to the brain-lymphatic pathway.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •College student ≥18 years, all of whom have passed a standardized entrance examination;
  • •No failed exams during the course of study;
  • •Sleep deprivation;
  • •In good health, with no mental or psychological disorders;
  • •No recent use of medications that may affect memory and cognition;
  • •Voluntary participation and able to undergo cognitive function and memory testing;
  • •Informed consent provided

排除标准

  • •Pregnant or breastfeeding women.
  • •Presence of acute or chronic medical conditions (e.g., severe hypertension, diabetes, cardiovascular disease) that could confound the results.
  • •History of craniocervical trauma or surgery.
  • •Current use of sedative or anxiolytic medications that could influence sleep or cognitive function.
  • •Participants who are unable to follow the procedures or complete the assessments

研究组 & 干预措施

NSCLD group

Experimental

NSCLD for 30 minutes, repeated after a 10-minute interval

干预措施: Non-Invasive Superficial Craniocervical Lymphatic Drainage (NSCLD) (Device)

Control group

Sham Comparator

干预措施: sham-intervention treatment (Device)

结局指标

主要结局

Digit Span Test

时间窗: Day 1 (Baseline) and Day 2, repeat after a 2-week washout period

Evaluate memory function. 1 point for each correct string of numbers. Total score: forward score + backward score. Higher scores mean a better outcome.

Montreal Cognitive Assessment (MoCA)

时间窗: Day 1 (Baseline) and Day 2, repeat after a 2-week washout period

The maximum score is 30 points. ≥26 points is normal. Higher scores mean a better outcome.

次要结局

  • Changes in anxiety, stress, irritability, etc. before and after instant massage(Day 1 (Baseline) and Day 2, repeat after a 2-week washout period)
  • Brain metabolic markers and other metabolic indicators(Day 1 (Baseline) and Day 2, repeat after a 2-week washout period)
  • EEG power in alpha, beta, delta and theta band(Day 1 (Baseline) and Day 2, repeat after a 2-week washout period)
  • Heart rate variability (HRV)(Day 1 (Baseline) and Day 2, repeat after a 2-week washout period)
  • modified TOEFL iBT(Day 1 (Baseline) and Day 2, repeat after a 2-week washout period)
  • Computerized Cognitive Assessment(Day 1 (Baseline) and Day 2, repeat after a 2-week washout period)
  • Functional magnetic resonance imaging (fMRI)(Day 1 (Baseline) and Day 2, repeat after a 2-week washout period)

研究者

发起方
Tao Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tao Liu

MD

The George Institute

研究点 (1)

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