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Идёт набор NCT07735910

Binaural Beats for Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes

Без фазы С лечением Mild Cognitive Impairment Cognitive Function

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: Binaural Beats Embedded in Old Songs, Old Songs.
Кому может быть актуально
Состояния в реестре: Mild Cognitive Impairment, Cognitive Function. Базовые параметры: от 60 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
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Официальное название

The Effect of Binaural Beats on Cognitive Function in Older Adults With Mild Cognitive Impairment in Nursing Homes: A Randomized Controlled Trial

Обзор

This study will evaluate whether binaural beats can improve cognitive function in older adults with mild cognitive impairment living in nursing homes. Participants will listen to 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days. Cognitive function, sleep quality, anxiety, and depressive symptoms will be assessed before the intervention, after the intervention, and at a 2-week follow-up after the intervention. The study aims to determine whether binaural beats are a safe, simple, and non-drug approach to support cognitive health in older adults with mild cognitive impairment.

Вмешательства

  • Поведенческое Binaural Beats Embedded in Old Songs
    Participants in the intervention group will listen to old songs embedded with 10-Hz alpha-frequency binaural beats through headphones once daily for 30 minutes for 14 consecutive days. The old songs will be selected according to older adults' music preferences.
  • Поведенческое Old Songs
    Participants in the control group will listen to old songs without binaural beats through headphones once daily for 30 minutes for 14 consecutive days. The old songs will be selected according to older adults' music preferences.

Первичные конечные точки

  • Change in Montreal Cognitive Assessment Score [Срок оценки: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
  • Change in Digit Span Test Score [Срок оценки: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
  • Change in Stroop Color-Word Test Score [Срок оценки: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
  • Change in Trail Making Test Score [Срок оценки: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
  • Change in Pittsburgh Sleep Quality Index Score [Срок оценки: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
  • Change in Geriatric Anxiety Scale Score [Срок оценки: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]
  • Change in Geriatric Depression Scale-15 Score [Срок оценки: Baseline, immediately after the 14-day intervention, and 2 weeks after the intervention]

Критерии участия

Критерии включения

  • Age 60 years or older.
  • Not previously diagnosed with dementia.
  • Meets the diagnostic criteria for mild cognitive impairment, with Montreal Cognitive Assessment scores adjusted by education level, Mini-Mental State Examination score >= 24, and Activities of Daily Living score < 23.
  • Has lived in a nursing home for more than 2 months and plans to continue living there during the study period.
  • No hearing impairment; Hearing Handicap Inventory for the Elderly-Screening Version score < 8, and able to hear binaural beats through both ears.
  • Conscious and able to cooperate with questionnaires and scale assessments.
  • Has not taken medications that may affect cognitive function within 3 to 6 months before the intervention.

Критерии исключения

  • Severe physical disease, major organ failure, or advanced malignant tumor.
  • Diagnosed depression or other psychiatric disorders.

Withdrawal Criteria:

  • Serious adverse events during the study, such as falls, disease recurrence, discomfort caused by the intervention audio, death, or other conditions making continued participation unsuitable.
  • Voluntary withdrawal from the study.

Removal Criteria:

  • Incomplete data resulting in missing information.
  • Missing three or more intervention sessions within 2 weeks without following intervention instructions.
  • Receiving other treatments or interventions related to cognitive function during the trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 3 центра
  • Jintaiyang Jingguan Elderly Care Apartment — Шэньян
  • Jintaiyang Elderly Care Center, Huanggu Branch — Шэньян
  • Renai Changwan Elderly Care Home, Dadong District — Шэньян

Идентификаторы

NCT: NCT07735910 · Lunshen [2025] 239

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗