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Could your smartphone replace a sleep lab?

NCT ID NCT04943562

Diagnosis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing whether wearable devices like activity trackers, EEG headbands, and smartphones can accurately measure sleep stages. Researchers will compare these devices to standard sleep lab tests (polysomnography) in 96 healthy volunteers and people with sleep disorders. If the devices prove reliable, they could offer a simpler, more accessible way to diagnose sleep problems at home.

What this could mean

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

What this could lead to
If successful, this could lead to a reliable, at-home method for diagnosing sleep disorders without needing a sleep lab.
What could go wrong
This is an early-stage validation study with only 96 participants. The wearable devices may not match the accuracy of standard polysomnography, and results may not apply to all sleep conditions.

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.

Participants

About 96 people

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

Started

Sep 2021

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.

Who is studied

Individuals from both genders, from 20 to 80 years old, healthy (at stage 1) or with at least one sleep disoder or complaint (at stage 2).

Ages

20 to 80 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.

FIRST STAGE (Healthy volunteers) Inclusion Criteria: * Age between 20 and 80 years old * Living in the city of São Paulo, Brazil * No physical or intellectual disability that prevent attending to a in-lab polysomnography or understanding its instructions. Exclusion Criteria: * Excessive daytime sleepiness (as measured by the Epworth Sleepiness Scale) * Poor sleep quality (as measured by the Pittsburgh Sleep Quality Index) * Insomnia symptoms at any level (as measured by the Insomnia Severity Index) * Symptoms of depression (as measured by the Beck Depression Inventory) * High risk to sleep apnea (as measured by the Stop-Bang questionnaire) * Presence of sleep-related symptoms (as measured by the UNIFESP (Federal University of São Paulo sleep questionnaire) * Self-reported abuse of alcohol, use of abuse drugs or use of medicine that might impact the normal sleep pattern (including hypnotics, benzodiazepines, antidepressants, corticosteroids, etc). * Self-reported chronic diseases * Diagnosis of any sleep disorders during the polysomnography SECONDS STAGE (volunteers with sleep disorders or complaints) Inclusion Criteria: * Age between 20 and 80 years old * Living in the city of São Paulo, Brazil * No physical or intellectual disability that prevent attending to a in-lab polysomnography or understanding its instructions. * At least one sleep disorder or sleep complaint. . Among these, at least 30% of the sample should have moderate to severe insomnia (as measured by the insomnia severity index), 30% should have high risk to sleep apnea (as measured by the STOP-BANG questionnaire) and 70% should have excessive sleepiness scale (as measured by the Epworth sleepiness scale). Exclusion criteria: * Absence of sleep disorders.

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Conditions

The condition(s) this trial relates to.

insomnia obstructive sleep apnea syndrome sleep disorder

As listed by the trial registrant

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

Insomnia Sleep Sleep apnea syndrome, obstructive

How to take part

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

  1. The places running it

    2 sites. 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

  • Centro de Especialistas do Sono

    RECRUITING

    São Paulo, 01416-001, Brazil

  • SleepUp Tecnologia em Saúde LTDA

    RECRUITING

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

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