ACT+EEG: Combination of ACT+EEG. This is not an intervention, but rather a combination of devices to be tested regarding its diagnostic validity.
Study 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
Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Sleep Latency — Immediately after the polysomnography. Time from the beginning of the polysomnographic record until the first epoch of sleep.
Total sleep time — Immediately after the polysomnography. Total time of epochs staged as sleep.
Sleep efficiency — Immediately after the polysomnography. Percentage of sleep in relation to total record/bed time.
Wake after sleep onset — Immediately after the polysomnography. Total time of epochs staged as "wake" after sleep latency.
Latency to REM sleep — Immediately after the polysomnography. Time from sleep latency until the first epoch of REM sleep.
Total time for each sleep stage — Immediately after the polysomnography. Time corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM)
Percentage each sleep stage — Immediately after the polysomnography. Percentage corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM), in comparison with total sleep time.
Trial sites (2)
Facility
City
Region
Status
SleepUp Tecnologia em Saúde LTDA
São Caetano do Sul
São Paulo
Recruiting
Centro de Especialistas do Sono
São Paulo
Brazil
Recruiting
More SleepUp Tecnologia em Saúde Ltda trials in Brazil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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