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

NCT07266415 | Active Not Recruiting DMC

• 1 other identifier: B-2501-950-302
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Insomnia; Pregnancy, First Trimester; Pregnancy, Second Trimester

Keywords

insomnia; pregnancy

Outcome Measures

Primary Outcomes (1)

• Primary outcome measurement

  Insomnia severity index

  1 week

Secondary Outcomes (13)

• 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

Study Arms (3)

Experimental group

EXPERIMENTAL

Device: Sleep inducing digital sound application

Sham-controlled group

SHAM COMPARATOR

Device: Provides meaningless sound in application

Control group

PLACEBO COMPARATOR

Sleep Hygiene Education in application

Device: Provides Sleep hygiene education text in application

Interventions

Sleep inducing digital sound application DEVICE

Application: BELL-001

Experimental group

Provides meaningless sound in application DEVICE

Sham application intervention

Sham-controlled group

Provides Sleep hygiene education text in application DEVICE

Placebo application

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• BELL Therapeutics Inc.: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: December 5, 2025
• Study Start: June 24, 2025
• Primary Completion: March 18, 2026
• Study Completion (Estimated): May 18, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-06

Locations

KR (1)