NCT07266415

Study for Pregnant Women With Insomnia Using Sleep Inducing Digital Sound Application

A 2-Week, Single-Center, Double-blind, Exploratory Study to Evaluate the Safety and Efficacy of the Sleep Inducing Digital Sound Application on Pregnant Women in Their 1st and 2nd Trimester With Insomnia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and efficacy of sleep inducing digital sound application on pregnant women in their 1st and 2nd trimester with insomnia

Detailed description

Duration of study period (per participant): Screening period (0-1 week), Intervention period (2 weeks), Follow-up period (1 week, without digital application use). Patient needs to visit the site at least 1 time (Screening). Other procedures will be conducted online. First visit is before the screening period, mainly to on-board patients and to train patients for accurate usage of the digital application.

Conditions

• Insomnia
• Pregnancy, First Trimester
• Pregnancy, Second Trimester

Interventions

Type	Name	Description
DEVICE	Sleep inducing digital sound application	Application: BELL-001
DEVICE	Provides meaningless sound in application	Sham application intervention
DEVICE	Provides Sleep hygiene education text in application	Placebo application

Timeline

• Start date: 2025-06-24
• Primary completion: 2026-03-18
• Completion: 2026-05-18
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: South Korea