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Can a smartphone app cure your sleepless nights?

NCT ID NCT04949360

Symptom relief Sponsor: SleepUp Tecnologia em Saúde Ltda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a smartphone app called SleepUp can help people with insomnia. The app provides cognitive-behavioral therapy (CBTi) and extra features like meditation and relaxation sounds. Researchers will compare the app to standard therapy with a psychologist and to basic sleep hygiene education. The goal is to see if the digital approach improves sleep and is easy for people to stick with.

What this could mean

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

Active substance
digital cognitive-behavioral therapy for insomnia (CBTi) app
What this could lead to
If successful, this could provide an effective, accessible digital treatment for insomnia that people can use at home.
What could go wrong
This is an early-stage trial with no phase designation. The digital therapy may not work as well as in-person therapy, and results may not apply to everyone with insomnia.

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

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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

20 to 60 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: * Literate Brazilian portuguese speakers. * Insomnia symptoms (as measured by ISI). * An Android-based smartphone or tablet with access to the Internet. Exclusion Criteria: * Previous experience with CBTi. * Use of sleeping pills or any other treatment for insomnia for two or more days a week in the last three months.

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Conditions

The condition(s) this trial relates to.

insomnia sleep disorder Sleep Hygiene sleep-wake disorder

As listed by the trial registrant

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

Insomnia Sleep disorder Sleep hygiene

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • SleepUp Tecnologia em Saúde LTDA

    RECRUITING

    São Caetano do Sul, São Paulo, 09530-250, Brazil

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