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Идёт набор NCT07084701

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

Без фазы С лечением Sleep Deprivation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Non-Invasive Superficial Craniocervical Lymphatic Drainage (NSCLD), sham-intervention treatment.
Кому может быть актуально
Состояния в реестре: Sleep Deprivation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство Non-Invasive Superficial Craniocervical Lymphatic Drainage (NSCLD)
    Participants will be randomly assigned to either an intervention group receiving NSCLD or a control group receiving a sham-intervention treatment. Cognitive function will be assessed using standardized tests before and after the intervention.
  • Устройство sham-intervention treatment
    Participants will be randomly assigned to either an intervention group receiving NSCLD or a control group receiving a sham-intervention treatment. Cognitive function will be assessed using standardized tests before and after the intervention.

Первичные конечные точки

  • Digit Span Test [Срок оценки: Day 1 (Baseline) and Day 2, repeat after a 2-week washout period]
  • Montreal Cognitive Assessment (MoCA) [Срок оценки: Day 1 (Baseline) and Day 2, repeat after a 2-week washout period]
Вторичные конечные точки (7)
  • Changes in anxiety, stress, irritability, etc. before and after instant massage [Срок оценки: Day 1 (Baseline) and Day 2, repeat after a 2-week washout period]
  • Brain metabolic markers and other metabolic indicators [Срок оценки: Day 1 (Baseline) and Day 2, repeat after a 2-week washout period]
  • EEG power in alpha, beta, delta and theta band [Срок оценки: Day 1 (Baseline) and Day 2, repeat after a 2-week washout period]
  • Heart rate variability (HRV) [Срок оценки: Day 1 (Baseline) and Day 2, repeat after a 2-week washout period]
  • modified TOEFL iBT [Срок оценки: Day 1 (Baseline) and Day 2, repeat after a 2-week washout period]
  • Computerized Cognitive Assessment [Срок оценки: Day 1 (Baseline) and Day 2, repeat after a 2-week washout period]
  • Functional magnetic resonance imaging (fMRI) [Срок оценки: Day 1 (Baseline) and Day 2, repeat after a 2-week washout period]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Tianjin Medical University General Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07084701 · NSCLD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗