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Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging

Key facts

Who runs it
SleepUp Tecnologia em Saúde Ltda
Where
Brazil2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
96 people, planned
Started
9 Sept 2021
Expected to end
1 Dec 2026
Type of study
Observational, 2 groups
Treatments tested
  • ACT+EEG
Record updated
2 December 2025

Who can take part

Age
20 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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
  • 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)

Who cannot take part

  • 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)
  • Absence of sleep disorders
  • 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)

Other criteria

  • FIRST STAGE (Healthy volunteers)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 20 and 80 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

This study aims to evaluate the viability of the combined use of wearable and portable technologies for sleep staging. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation. Three domains of devices will be used: Movement sensors, wearable EEG band and smartphones

Read full original descriptionShow less

The project will be composed of two stages:

In the first stage, the use of the combination of actigraphy and EEG will be used for sleep staging in a sample of 12 healthy volunteers from 20 to 80 years old, both genders and with no sleep disorders for each combination of ACT+EEG. Considering there will two of each (thus four combinations), the final sample will be composed of 48 individuals. Once recruited, evaluated according to the inclusion and exclusion criteria and consented with the terms of this study, the participants will be referred to the sleep lab, in which they will undergo a full night type-1 in lab polysomnography, following the setup recommended by the American Academy of Sleep Medicine. Concomitantly with the polysomnography, the participants will also use the combination of ACT+EEG.

In the second stage, the most successful combination tested in the first stage will be tested in a clinical sample, composed by 60 participants from both genders, from 20 to 80 years old and with at least one sleep disorder or complaint. Among these, at least 30% of the sample should have moderate to severe insomnia, 30% should have high risk to sleep apnea and 70% should have excessive sleepiness scale. All the procedures, including the polysomnography will be performed identically to the first step.

The 2 groups in the trial

  • Healthy participants

    Participants from 20 to 80 years old, from both genders and with no sleep disorders

    Treatment: ACT+EEG

  • Participants with sleep disorders

    Participants between the ages of 20 and 80 years who reported one or more sleep-related disorders or complaints. 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).

    Treatment: ACT+EEG

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of the Viability of Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging in Comparison With Polysomnography
Fit questions
Built from NCT04943562, who can take part
Record updated
2 December 2025