Using wearable technology to improve sleep staging

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

This study is testing whether using wearable devices and smartphones can help improve how we track and understand sleep patterns in healthy young adults compared to traditional sleep studies.

Quick facts

• Study type: Observational
• Enrollment: 96 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: SleepUp Tecnologia em Saúde Ltda (Industry-sponsored)
• Locations: 2 sites (São Caetano do Sul, São Paulo and 1 other locations)
• Trial ID: NCT04943562 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of combining wearable devices, including movement sensors and EEG bands, with smartphones for accurate sleep staging. It involves two stages, starting with a sample of 48 healthy volunteers aged 20 to 40, who will undergo polysomnography to validate the data collected from these devices. The goal is to compare the results from these technologies against traditional sleep studies to enhance diagnostic capabilities for sleep disorders.

Who should consider this trial

Good fit: Ideal candidates are healthy volunteers aged 20 to 40 living in São Paulo, Brazil, with no sleep disorders.

Not a fit: Patients with existing sleep disorders or related symptoms will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more accessible and accurate method for diagnosing sleep disorders.

How similar studies have performed: While the use of wearable technology for sleep monitoring is gaining traction, this specific combination of devices is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

São Caetano do Sul, São Paulo and 1 other locations

• SleepUp Tecnologia em Saúde LTDA — São Caetano do Sul, São Paulo, Brazil (Recruiting)
• Centro de Especialistas do Sono — São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Gabriel Pires, PhD — Instituto do Sono
• Study coordinator: Renata Bonaldi, PhD

Conditions Sleep; Insomnia; Sleep Apnea Syndrome, Obstructive