Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging

Официальное название

Evaluation of the Viability of Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging in Comparison With Polysomnography

Обзор

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.

Подробное описание

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: Devices equipped with movement sensors (such as an accelerometer) able to monitor movement over the using period, converting this information in data related to the sleep-wakefulness cycle. In this category, the reference devices are the actimeters/actigraphs (ACT). Its use is recommended by the American Academy of Sleep Medicine to the diagnosis of insomnia and circadian sleep disorders, and should be used for 3 to 14 consecutive days. Other wearable devices, such as smartwatches, are also used with the same purpose, although not validated for clinical use. In this study two wearable devices with movement sensors will be used, with the following minimal specifications: accelerometer in three axes, minimal sampling rate of 25Hz, maximum weight of 100g, battery lasting at least a week and support for Bluetooth connection. The desirable criteria are: light, body temperature and hearth rhythm sensors. * Wearable EEG band: EEG is a mandatory feature for type-1 polysomnography and a requirement for regular sleep staging. In this project, the EEG will be used in combination with actigraphy to allow a better estimation of sleep stages. In this study two wearable EEG bands will be tested, with the following minimal specifications: dry EEG electrode (no need of paste, gel or other conductor), presented as a head band or stripe, minimal sampling rate of 500Hz, noise, high and low filters, battery lasting at least 8h, maximum weight of 200g (including the whole device) and support for Bluetooth connection. * Smartphones: Additionally to the movement sensors and the EEG bands, the evaluation of sleep pattern will be based on smartphone-based accelerometers. This is the most common approach among the currently available sleep tracking applications, although is the least accurate. In this project the smartphones will be equipped with SleepUp's app and its sleep tracking functionality.

The project will be composed of three 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 (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). All the procedures, including the polysomnography will be performed identically to the first step.

Вмешательства

• Диагностический тест ACT+EEG
  Combination of ACT+EEG. This is not an intervention, but rather a combination of devices to be tested regarding its diagnostic validity.

Первичные конечные точки

• Sleep Latency [Срок оценки: Immediately after the polysomnography.]
• Total sleep time [Срок оценки: Immediately after the polysomnography.]
• Sleep efficiency [Срок оценки: Immediately after the polysomnography.]
• Wake after sleep onset [Срок оценки: Immediately after the polysomnography.]
• Latency to REM sleep [Срок оценки: Immediately after the polysomnography.]
• Total time for each sleep stage [Срок оценки: Immediately after the polysomnography.]
• Percentage each sleep stage [Срок оценки: Immediately after the polysomnography.]

Критерии участия

FIRST STAGE (Healthy volunteers)

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии включения

• 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).

Критерии исключения

• Absence of sleep disorders.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бразилия · 2 центра

• SleepUp Tecnologia em Saúde LTDA — São Caetano do Sul
• Centro de Especialistas do Sono — São Paulo

Публикации

• Melo MC, da Silva Vallim JR, Garbuio S, Soster LA, Sousa KMM, Bonaldi RR, Pires GN. Validation of a sleep staging classification model for healthy adults based on two combinations of a single-channel EEG headband and wrist actigraphy. J Clin Sleep Med. 2024 Jun 1;20(6):983-990. doi: 10.5664/jcsm.11082. PMID 38427322

Идентификаторы

NCT: NCT04943562 · SleepUp_#02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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