NCT04943562

Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging

Recruiting now Last updated 2 December 2025

What this trial tests

trial testing ACT+EEG in Sleep in 96 participants. Currently enrolling.

Timeline

9 September 2021

Primary endpoint
12 December 2021

1 December 2026

Quick facts

Lead sponsor	SleepUp Tecnologia em Saúde Ltda
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	96
Start date	9 September 2021
Primary completion	12 December 2021
Estimated completion	1 December 2026
Sites	2 locations across Brazil

Drugs / interventions tested

• ACT+EEG

Conditions studied

• Sleep — all drugs for Sleep →
• Insomnia — all drugs for Insomnia →
• Sleep Apnea Syndrome, Obstructive — all drugs for Sleep Apnea Syndrome, Obstructive →

Sponsor

SleepUp Tecnologia em Saúde Ltda

Who can join

Adults 20 to 80, any sex, with Sleep or Insomnia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Validation of a sleep staging classification model for healthy adults based on two combinations of a single-channel EEG headband and wrist actigraphy.
   Melo MC, da Silva Vallim JR, Garbuio S, Soster LA, et al · · 2024 · cited 2× · PMID 38427322 · DOI 10.5664/jcsm.11082