Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07266415

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Pregnancy, First Trimester Pregnancy, Second Trimester Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep inducing digital sound application

Device

Application: BELL-001

Provides meaningless sound in application

Device

Sham application intervention

Provides Sleep hygiene education text in application

Device

Placebo application

Primary outcomes

  1. Primary outcome measurement

    Time frame: 1 week

    Insomnia severity index

Secondary outcomes

  1. Sleep Latency (SL, Minutes), assessed using a sleep diary

    Time frame: 1 week

  2. Sleep Latency (SL, Minutes), assessed using a smartwatch

    Time frame: 1 week

  3. Sleep Efficiency (SE, Percentage), assessed using a sleep diary

    Time frame: 1 week

  4. Sleep Efficiency (SE, Percentage), assessed using a smartwatch

    Time frame: 1 week

  5. Wake After Sleep Onset (WASO, Minutes), assessed using a sleep diary

    Time frame: 1 week

  6. Wake After Sleep Onset (WASO, Minutes), assessed using a smartwatch

    Time frame: 1 week

  7. Total Sleep Time (TST, Minutes), assessed using a sleep diary

    Time frame: 1 week

  8. Total Sleep Time (TST, Minutes), assessed using a smartwatch

    Time frame: 1 week

  9. Sleep Quality (SQ, Score 1-10; bad-good), assessed using a sleep diary

    Time frame: 1 week

  10. Pittsburgh Sleep Quality Index (PSQI, Score 0-21; better-worse)

    Time frame: 2 weeks

  11. Edinburgh Postnatal Depression Scale (EPDS, Score 0-30; better-worse)

    Time frame: 2 weeks

  12. Generalized Anxiety Disorder-7 (GAD-7, Score 0-21; better-worse)

    Time frame: 2 weeks

  13. Pregnancy-Related Anxiety Questionnaire (PRAQ, Score 32-128; better-worse)

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • BELL Therapeutics Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.