NCT04943562 Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 96 participants in total. It began in 2021-09-09 with a primary completion date of 2021-12-12.

Brief Summary

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

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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