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Sound sleep app tested for pregnancy insomnia

NCT ID NCT07266415

Symptom relief Sponsor: Seoul National University Bundang Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special sound app designed to help pregnant women in their first or second trimester who have trouble sleeping. Thirty women will use the app for two weeks, and researchers will track their sleep quality using diaries and smartwatches. The goal is to see if the app is safe and effective for easing insomnia during early pregnancy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Jun 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Pregnancy, first trimester Pregnancy, second trimester

Contacts and locations

Locations

  • Seoul National University Bundang Hospital

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.