Using wearable technology to improve sleep staging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: pesquisa@sleepup.com.br
• Phone: +55 11 933191375

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.