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

NCT07266415 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-05

No results posted yet for this study

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

Interventions

DEVICE

Sleep inducing digital sound application

Application: BELL-001

DEVICE

Provides meaningless sound in application

Sham application intervention

DEVICE

Provides Sleep hygiene education text in application

Placebo application

Sponsors & Collaborators

  • BELL Therapeutics Inc.

    collaborator INDUSTRY

  • Seoul National University Bundang Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-24
Primary Completion
2026-03-18
Completion
2026-05-18

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266415 on ClinicalTrials.gov