InsomniaNCT07266415
Study for Pregnant Women With Insomnia Using Sleep Inducing Digital Sound Application
A study testing Sleep inducing digital sound application, Provides meaningless sound in application and Provides Sleep hygiene education text in application in people with Insomnia and Pregnancy, First Trimester, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Insomnia, Pregnancy, First Trimester, Pregnancy, Second Trimester
- What is being tested?
- Sleep inducing digital sound application, Provides meaningless sound in application and Provides Sleep hygiene education text in application
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jun 2025to 18 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official 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
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
Read the 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.
- Being tested
- Sleep inducing digital sound application, Provides meaningless sound in application, Provides Sleep hygiene education text in application
- Keywords
- insomnia, pregnancy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep inducing digital sound applicationDevice
Application: BELL-001
Provides meaningless sound in applicationDevice
Sham application intervention
Provides Sleep hygiene education text in applicationDevice
Placebo application
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Device: Sleep inducing digital sound application |
| Sham-controlled group | Sham comparator | Not described Receives: Device: Provides meaningless sound in application |
| Control group | Placebo comparator | Sleep Hygiene Education in application Receives: Device: Provides Sleep hygiene education text in application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measurement
Insomnia severity index
Measured: 1 week
Secondary outcomes (13)
Sleep Latency (SL, Minutes), assessed using a sleep diary
Measured: 1 week
Sleep Latency (SL, Minutes), assessed using a smartwatch
Measured: 1 week
Sleep Efficiency (SE, Percentage), assessed using a sleep diary
Measured: 1 week
Sleep Efficiency (SE, Percentage), assessed using a smartwatch
Measured: 1 week
Wake After Sleep Onset (WASO, Minutes), assessed using a sleep diary
Measured: 1 week
Wake After Sleep Onset (WASO, Minutes), assessed using a smartwatch
Measured: 1 week
Total Sleep Time (TST, Minutes), assessed using a sleep diary
Measured: 1 week
Total Sleep Time (TST, Minutes), assessed using a smartwatch
Measured: 1 week
Sleep Quality (SQ, Score 1-10; bad-good), assessed using a sleep diary
Measured: 1 week
Pittsburgh Sleep Quality Index (PSQI, Score 0-21; better-worse)
Measured: 2 weeks
Edinburgh Postnatal Depression Scale (EPDS, Score 0-30; better-worse)
Measured: 2 weeks
Generalized Anxiety Disorder-7 (GAD-7, Score 0-21; better-worse)
Measured: 2 weeks
Pregnancy-Related Anxiety Questionnaire (PRAQ, Score 32-128; better-worse)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start24 Jun 2025
- Primary completion18 Mar 2026 (estimated)
- Study completion18 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BELL Therapeutics Inc.
- Responsible party
- Principal investigator, Jee Yoon Park, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266415
- Sponsor's protocol ID
- B-2501-950-302
- Status last verified
- Jun 2025
- First submitted
- 20 Apr 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07266415
- Acronym / sponsor ID
- B-2501-950-302
- Keywords
- insomnia, pregnancy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- BELL Therapeutics Inc.
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 18 Mar 2026 (estimated)
- Study completion
- 18 May 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Sleep inducing digital sound application |
| Sham-controlled group | Sham comparator | Device: Provides meaningless sound in application |
| Control group | Placebo comparator | Device: Provides Sleep hygiene education text in applicationSleep Hygiene Education in application |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep inducing digital sound applicationApplication: BELL-001 | Device | Experimental group |
| Provides meaningless sound in applicationSham application intervention | Device | Sham-controlled group |
| Provides Sleep hygiene education text in applicationPlacebo application | Device | Control group |
Primary outcome
Primary outcome measurement
Time frame: 1 week
Insomnia severity index
13 secondary outcomes
Sleep Latency (SL, Minutes), assessed using a sleep diary
Time frame: 1 week
Sleep Latency (SL, Minutes), assessed using a smartwatch
Time frame: 1 week
Sleep Efficiency (SE, Percentage), assessed using a sleep diary
Time frame: 1 week
Sleep Efficiency (SE, Percentage), assessed using a smartwatch
Time frame: 1 week
Wake After Sleep Onset (WASO, Minutes), assessed using a sleep diary
Time frame: 1 week
Wake After Sleep Onset (WASO, Minutes), assessed using a smartwatch
Time frame: 1 week
Total Sleep Time (TST, Minutes), assessed using a sleep diary
Time frame: 1 week
Total Sleep Time (TST, Minutes), assessed using a smartwatch
Time frame: 1 week
Sleep Quality (SQ, Score 1-10; bad-good), assessed using a sleep diary
Time frame: 1 week
Pittsburgh Sleep Quality Index (PSQI, Score 0-21; better-worse)
Time frame: 2 weeks
Edinburgh Postnatal Depression Scale (EPDS, Score 0-30; better-worse)
Time frame: 2 weeks
Generalized Anxiety Disorder-7 (GAD-7, Score 0-21; better-worse)
Time frame: 2 weeks
Pregnancy-Related Anxiety Questionnaire (PRAQ, Score 32-128; better-worse)
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep inducing digital sound application, Provides meaningless sound in application and Provides Sleep hygiene education text in application in people with Insomnia and Pregnancy, First Trimester, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measurement (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.