Testing Wearable Movement Sensors, EEG Bands, and Smartphones for Sleep Monitoring Compared to Polysomnography in Adults Aged 20 to 80
Led by SleepUp Tecnologia em Saúde Ltda · Updated on 2025-12-02
96
Participants Needed
2
Research Sites
259 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of combined wearable and portable devices for sleep staging, comparing their results with standard polysomnography to achieve clinical and diagnostic validation. The study focuses on three types of devices movement sensors actigraphy, wearable EEG bands, and smartphones. This observational study involves healthy participants and those with sleep disorders, aiming to assess the accuracy of these technologies for sleep monitoring.
The study is conducted in two stages. In the first stage, combinations of actigraphy and wearable EEG bands will be tested on 48 healthy volunteers aged 20 to 80 years without sleep disorders. Participants will undergo overnight polysomnography while simultaneously using the device combinations. In the second stage, the most effective combination from stage one will be tested on 60 participants aged 20 to 80 years who have at least one sleep disorder or complaint, including insomnia, sleep apnea risk, or excessive sleepiness. All participants will undergo the same procedures.
Participants will visit a sleep lab for a full night of type-1 polysomnography conducted according to recommended standards, while also wearing the study devices. Researchers will measure various sleep parameters immediately after polysomnography, including sleep latency, total sleep time, sleep efficiency, wake after sleep onset, latency to REM sleep, and the time and percentage of each sleep stage. The study will monitor these outcomes to evaluate the diagnostic validity of the wearable and portable devices compared to polysomnography.
CONDITIONS
Brief Title
Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging
Research Team
R
Renata Bonaldi, PhD
R
Renata Bonaldi, PhD
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No physical or intellectual disability that prevents attending an in-lab polysomnography or understanding its instructions
For stage one: no sleep disorders
For stage two: at least one sleep disorder or complaint, with specified proportions having moderate to severe insomnia, high risk of sleep apnea, or excessive sleepiness
You will not qualify if you...
Excessive daytime sleepiness (Epworth Sleepiness Scale) for healthy volunteers
Poor sleep quality (Pittsburgh Sleep Quality Index) for healthy volunteers
Any insomnia symptoms (Insomnia Severity Index) for healthy volunteers
Symptoms of depression (Beck Depression Inventory) for healthy volunteers
High risk for sleep apnea (Stop-Bang questionnaire) for healthy volunteers
Presence of sleep-related symptoms (UNIFESP sleep questionnaire) for healthy volunteers
Abuse of alcohol, drugs, or use of medicines affecting sleep
Chronic diseases
Diagnosis of any sleep disorder during polysomnography
For stage two: absence of sleep disorders
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 night
Participants undergo full night type-1 in-lab polysomnography while simultaneously using wearable devices including actigraphy and EEG bands to evaluate sleep staging.
1 overnight visit (in-person)
Long-term Monitoring
Duration - 3 to 14 consecutive days
Participants wear movement sensors (actigraphy) and use smartphone apps to monitor sleep-wakefulness cycles over several days to 2 weeks.
Continuous monitoring with wearable devices during this period
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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