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临床试验/NCT07699536
NCT07699536招募中不适用

Prenatal Music Exposure to Enhance Postnatal Language Development

Chinese University of Hong Kong2 个研究点 分布在 2 个国家目标入组 480 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
入组人数
480
试验地点
2
主要终点
Neural encoding of speech as measured by EEG

研究概览

简要总结

The goal of this randomized controlled study is to evaluate the effect of prenatal music exposure on infants through two years of age.

The study addresses two primary questions:

  • Whether prenatal music exposure enhances neural encoding of speech and improve language and cognitive outcomes during the first two years of life among fetuses
  • Whether predictive models can be developed from available fetal data to forecast individual differences in developmental outcomes among fetuses exposed to prenatal music.

Participants will engage in music listening or self-learning five days a week until delivery. After the participants give birth, the children will be followed up on their neural responses to speech, as well as their language and cognitive development, until they reach two years of age.

The investigators will compare the effects of low- and high-dose prenatal music exposure with a control group receiving education and develop models to predict outcomes in fetuses exposed to prenatal music.

详细描述

[BACKGROUND] Fetuses can hear in the womb from as early as 20 weeks of gestation. Research has shown that prenatal music and spoken language experiences are related to better neural and behavioral outcomes at birth. These findings, though focused on outcomes shortly after birth, are consistent with a larger body of research showing positive effects of postnatal music training on children's language and cognitive outcomes.

[AIM OF STUDY] Objective 1: To examine whether prenatal music exposure leads to better neural encoding of speech and better language and cognitive developmental outcomes up to two years of life.

Objective 2: To construct predictive models using fetal data (e.g., fetal brain MRI and ultrasound data, if available) to forecast individual differences in developmental outcomes among fetuses exposed to prenatal music.

[HYPOTHESIS] The investigators hypothesize that prenatal music exposure can strengthen a fetus's neural encoding of speech from birth, leading to better language and cognitive development in early childhood. The investigators further hypothesize that, despite the expected heterogeneity in intervention effects, fetal features can predict how much a fetus would benefit from prenatal music exposure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • residents of the Greater Bay Area (GBA) with Cantonese and/or Putonghua being the primary home language(s)
  • aged 18 years or above
  • single fetus pregnancy
  • Less than 32 weeks of gestation

排除标准

  • 未提供

研究组 & 干预措施

Education

Placebo Comparator

Participants will learn independently from educational materials

干预措施: Education (Other)

High-dose music

Experimental

Participants will be exposed to a higher dose of music

干预措施: High dose music Exposure (Other)

Low-dose music

Active Comparator

Participants will be exposed to a lower dose of music

干预措施: Low dose music exposure (Other)

结局指标

主要结局

Neural encoding of speech as measured by EEG

时间窗: Birth to 1 month, and at 6, 12, and 24 months of age

Comparing the ability of neural encoding of speech as measured by EEG between groups.

次要结局

  • Chinese Communicative Development Inventories (CCDI)(12, and 24 months old)
  • Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4)(6, 12, and 24 months old)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick C. M. Wong

Professor

Chinese University of Hong Kong

研究点 (2)

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