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

NCT ID: NCT07266415

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-24
• Study Completion Date: 2026-05-18

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

Sleep inducing digital sound application

Intervention Type: DEVICE

Application: BELL-001

Sham-controlled group

Group Type: SHAM_COMPARATOR

Provides meaningless sound in application

Intervention Type: DEVICE

Sham application intervention

Control group

Sleep Hygiene Education in application

Group Type: PLACEBO_COMPARATOR

Provides Sleep hygiene education text in application

Intervention Type: DEVICE

Placebo application

Interventions

Sleep inducing digital sound application

Application: BELL-001

Intervention Type: DEVICE

Provides meaningless sound in application

Sham application intervention

Intervention Type: DEVICE

Provides Sleep hygiene education text in application

Placebo application

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

BELL Therapeutics Inc.

INDUSTRY

Sponsor Role: collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jee Yoon Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-2501-950-302

Identifier Type: -

Identifier Source: org_study_id