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Can a phone app cure your insomnia? new trial tests sound therapy that syncs with your breath

NCT ID NCT07295431

Symptom relief Sponsor: BELL Therapeutics Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 2 times

Summary

This study tests a smartphone app called BELL-001 that plays personalized sounds in sync with your breathing to help you relax and fall asleep. 114 adults with insomnia will use the app or a sham version nightly for 4 weeks. Researchers will measure changes in sleep quality and daytime function to see if the app works as a safe, drug-free treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
smartphone-based digital therapeutic delivering personalized auditory stimulation synchronized with breathing
What this could lead to
If successful, this could provide a safe, non-drug option to help people with insomnia fall asleep more easily and improve daytime function.
What could go wrong
This is an early-stage trial with only 114 participants, and the sham control may show similar effects. The app may not work for everyone, and long-term benefits are unknown.

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

116 people

The number who actually took part.

Started

Mar 2026

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

19 to 75 years

Sex

Anyone

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: * Adults aged 19 to 75 years. * Clinical diagnosis of insomnia disorder according to ICD-10 criteria (non-organic insomnia or sleep initiation/maintenance disorder). * Insomnia Severity Index (ISI) score ≥ 15 at screening. * Reports difficulty initiating or maintaining sleep at least 3 nights per week for ≥ 3 months. * Willing and able to use a smartphone-based digital therapeutic during the pre-sleep period for 4 weeks. * Able to provide informed consent and comply with study procedures. Exclusion Criteria: * Other primary sleep disorders (e.g., obstructive sleep apnea, restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorders). * Major psychiatric disorders that may interfere with study assessment (e.g., psychotic disorders, bipolar disorder, severe major depressive episode). * Substance use disorder, including alcohol or hypnotic misuse, within the past 12 months. * Use of sleep-inducing medications or CNS-active drugs that cannot be stabilized or discontinued per protocol. * Significant medical or neurological conditions that may affect sleep or study outcomes (e.g., severe cardiovascular, respiratory, or neurological disease). * Night-shift workers or individuals with irregular sleep-wake schedules. * Pregnancy or breastfeeding. * Participation in another interventional clinical study within the past 30 days. * Any condition judged by the investigator to interfere with study participation, safety, or data validity.

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Conditions

The condition(s) this trial relates to.

insomnia sleep disorder, initiating and maintaining sleep

As listed by the trial registrant

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

Insomnia Sleep initiation and maintenance disorders

Contacts and locations

Locations

  • CHA Bundang Hospital

    Seoul, South Korea

  • Catholic Kwandong University International St. Mary's Hospital

    Seoul, South Korea

  • Kangbuk Samsung Hospital

    Seoul, South Korea

  • Kyung Hee University Hospital at Gangdong

    Seoul, South Korea

  • Kyung Hee University Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

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