About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial population
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).
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
ACT+EEG
Diagnostic testCombination of ACT+EEG. This is not an intervention, but rather a combination of devices to be tested regarding its diagnostic validity.
Treatment groups
Trial outcomes
Primary outcomes
Sleep Latency
Time from the beginning of the polysomnographic record until the first epoch of sleep.
Total sleep time
Total time of epochs staged as sleep.
Sleep efficiency
Percentage of sleep in relation to total record/bed time.
Wake after sleep onset
Total time of epochs staged as "wake" after sleep latency.
Sponsors and contacts
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