Study for Pregnant Women With Insomnia Using Sleep Induci... | NCT07266415

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

NCT07266415

Sponsor

Seoul National University Bundang Hospital

Status

Active, not recruiting

Last Update Posted

Dec 5, 2025Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Insomnia
Pregnancy, First Trimester
Pregnancy, Second Trimester

Interventions

Sleep inducing digital sound application
Provides meaningless sound in application
Provides Sleep hygiene education text in application

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2025Actual

Primary Completion Date

Mar 18, 2026Estimated

Completion Date

May 18, 2026Estimated

First Submitted Date

Apr 20, 2025

First Submission Date that Met QC Criteria

Nov 24, 2025

First Posted Date

Dec 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Dec 5, 2025Actual

Name	Class
BELL Therapeutics Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sleep inducing digital sound application	Device	Application: BELL-001	Experimental group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	13620	South Korea

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D001523	Mental Disorders