Prenatal Music Exposure to Enhance Postnatal Language Development

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Other: High dose music Exposure; Other: Low dose music exposure; Other: Education

Detailed Description

[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.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peggy Chan, PhD; Phone Number: +852 3943 9443; Email: peggy.chan@cuhk.edu.hk

Study Locations

• China
  • Shenzhen, China
    • Recruiting
    • BaoAn Hospital
    • Contact: Peggy Chan, PhD; Phone Number: +852 39439443; Email: peggy.chan@cuhk.edu.hk
    • Principal Investigator: B Sun, MD
    • Principal Investigator: Q Shi, MD
    • Principal Investigator: H Wang, MD
    • Sub-Investigator: XH Wei, MD
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Prince of Wales Hospital
    • Contact: Peggy Chan, PhD; Phone Number: +852 39439443; Email: peggy.chan@cuhk.edu.hk
    • Principal Investigator: HS Lam, MD
    • Principal Investigator: CWW Chu, MD
    • Principal Investigator: TY Leung, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-dose music; Participants will be exposed to a higher dose of music	Other: High dose music Exposure; Participants will be exposed to children's songs in various languages for 40 minutes daily, five days per week, with 80% of songs presented at approximately 75 dB SPL and 20% at approximately 10 dB SPL.
Active Comparator: Low-dose music; Participants will be exposed to a lower dose of music	Other: Low dose music exposure; Participants will be exposed to children's songs in various languages for 15 minutes daily, five days per week, with 20% of songs presented at approximately 75 dB SPL and 80% at approximately 10 dB SPL.
Placebo Comparator: Education; Participants will learn independently from educational materials	Other: Education; Participants will learn independently from short educational videos and audios on pregnancy, maternal and child health, and parenting, five days a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neural encoding of speech as measured by EEG	Comparing the ability of neural encoding of speech as measured by EEG between groups.	Birth to 1 month, and at 6, 12, and 24 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chinese Communicative Development Inventories (CCDI)	Comparing language and communicative abilities, as measured by the Chinese Communicative Development Inventories (CCDI), between groups.	12, and 24 months old
Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4)	Five developmental domains (and subdomains): Cognitive, Language (Receptive and Expressive Communication subdomains), Motor (fine and gross motor subdomains), Social-emotional, and Adaptive Behavior will be assessed and compared across groups. The domain standard scores range from 45-155, and the subdomain scaled scores range from 1- 19 . Higher scores indicate better outcomes.	6, 12, and 24 months old

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in stress score on the Perceived Stress Scale (PSS)	PSS stress score ranges from 0 to 40, with higher scores indicating higher perceived stress.	From recruitment to 24 months old
Change from baseline in depression score on the Edinburgh Postnatal Depression Scale (EPDS)	The depression score ranges from 0 to 30, with a higher score indicating a high likelihood of depression.	From recruitment to 12 months old
Change from baseline in maternal knowledge of child development on the 20-item short form of the Knowledge of Infant Development Inventory (KIDI) across groups	Total correct score ranges from 0- 20	Recruitment and birth to 1 month old
Maternal sleep behavior measured by the Pittsburgh Sleep Quality Index (PSQI)		From recruitment to 24 months old
Brief Infant Sleep Questionnaire (BISQ)		6, 12, and 24 months old
Child development, emotion, and behavior measured by the Survey of Well-being of Young Children (SWYC)		6, 12, and 24 months old
Mother-infant attachment measured by the Postpartum Bonding Questionnaire (PBQ)	The PBQ score ranges from 0 to 125; the higher scores mean a poorer outcome.	0-1months, 6, and 12 months old

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Language; Pregnancy; EEG; Predictive model; Cognitive; Neural encoding; Prenatal music; Music exposure
• Additional Relevant MeSH Terms: Behavior; Communication; Language; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: C4055-19GF; 2023.354 (Other Identifier: Joint CUHK-NTEC Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No