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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Insomnia; Pregnancy, First Trimester; Pregnancy, Second Trimester
• Intervention / Treatment: Device: Sleep inducing digital sound application; Device: Provides meaningless sound in application; Device: Provides Sleep hygiene education text in application

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 19 years older
• pregnant women in their 1st and 2nd trimester
• suffering from insomnia symptom
• scored 10 or high in screening ISI
• a person who voluntarily agreed to participate in this RCT

Exclusion Criteria:

• Has a confirmed diagnosis of insomnia disorder other than chronic insomnia based on DSM-5(ex. Narcolepsy, Periodic Limb Movement, Restless Leg syndrome, etc)
• Has a confirmed diagnosis of other neuropsychiatric disease
• Has an history of suicidal ideat or attempt
• Shift worker
• Going through other interventions regarding insomnia(sleeping pills, light therapy, other alternative interventions)
• Has a severe auditory, visual, or cognitive impairment
• A person who cannot familiarize with the usage of smartphones and digital applications
• Has a history of alcohol or other substance use disorder
• A person with high risk pregnancy considered inadequate to participate in this trial by obstetric experts
• A person considered inadequate to participate in this trial by a clinical expert

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Device: Sleep inducing digital sound application; Application: BELL-001
Sham Comparator: Sham-controlled group	Device: Provides meaningless sound in application; Sham application intervention
Placebo Comparator: Control group; Sleep Hygiene Education in application	Device: Provides Sleep hygiene education text in application; Placebo application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome measurement	Insomnia severity index	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Sleep Latency (SL, Minutes), assessed using a sleep diary	1 week
Sleep Latency (SL, Minutes), assessed using a smartwatch	1 week
Sleep Efficiency (SE, Percentage), assessed using a sleep diary	1 week
Sleep Efficiency (SE, Percentage), assessed using a smartwatch	1 week
Wake After Sleep Onset (WASO, Minutes), assessed using a sleep diary	1 week
Wake After Sleep Onset (WASO, Minutes), assessed using a smartwatch	1 week
Total Sleep Time (TST, Minutes), assessed using a sleep diary	1 week
Total Sleep Time (TST, Minutes), assessed using a smartwatch	1 week
Sleep Quality (SQ, Score 1-10; bad-good), assessed using a sleep diary	1 week
Pittsburgh Sleep Quality Index (PSQI, Score 0-21; better-worse)	2 weeks
Edinburgh Postnatal Depression Scale (EPDS, Score 0-30; better-worse)	2 weeks
Generalized Anxiety Disorder-7 (GAD-7, Score 0-21; better-worse)	2 weeks
Pregnancy-Related Anxiety Questionnaire (PRAQ, Score 32-128; better-worse)	2 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: BELL Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2025
• Primary Completion (Estimated): March 18, 2026
• Study Completion (Estimated): May 18, 2026

Study Registration Dates

• First Submitted: April 20, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: insomnia; pregnancy
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: B-2501-950-302

Drug and device information, study documents

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