Actively Recruiting
Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging
Led by SleepUp Tecnologia em Saúde Ltda · Updated on 2025-12-02
96
Participants Needed
2
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 80 years old
- Living in the city of São Paulo, Brazil
- No physical or intellectual disability that prevents attending an in-lab polysomnography or understanding its instructions
- For healthy volunteers: no sleep disorders or complaints
- For clinical participants: at least one sleep disorder or complaint, including moderate to severe insomnia, high risk of sleep apnea, or excessive sleepiness as measured by standard questionnaires
You will not qualify if you...
- Excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (for healthy volunteers)
- Poor sleep quality as measured by the Pittsburgh Sleep Quality Index (for healthy volunteers)
- Insomnia symptoms at any level as measured by the Insomnia Severity Index (for healthy volunteers)
- Symptoms of depression as measured by the Beck Depression Inventory (for healthy volunteers)
- High risk of sleep apnea as measured by the STOP-BANG questionnaire (for healthy volunteers)
- Presence of sleep-related symptoms as measured by the UNIFESP sleep questionnaire (for healthy volunteers)
- Self-reported abuse of alcohol, use of abuse drugs, or use of medicine that might impact normal sleep patterns
- Self-reported chronic diseases
- Diagnosis of any sleep disorder during polysomnography (for healthy volunteers)
- Absence of sleep disorders (for clinical participants)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
SleepUp Tecnologia em Saúde LTDA
São Caetano do Sul, São Paulo, Brazil, 09530-250
Actively Recruiting
2
Centro de Especialistas do Sono
São Paulo, Brazil, 01416-001
Actively Recruiting
Research Team
R
Renata Bonaldi, PhD
CONTACT
R
Renata Bonaldi, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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