Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging
Evaluation of the Viability of Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging in Comparison With Polysomnography
1 other identifier
observational
96
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2021
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2021
CompletedFirst Posted
Study publicly available on registry
June 29, 2021
CompletedStudy Start
First participant enrolled
September 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedDecember 2, 2025
November 1, 2025
3 months
June 13, 2021
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
Sleep Latency
Time from the beginning of the polysomnographic record until the first epoch of sleep.
Immediately after the polysomnography.
Total sleep time
Total time of epochs staged as sleep.
Immediately after the polysomnography.
Sleep efficiency
Percentage of sleep in relation to total record/bed time.
Immediately after the polysomnography.
Wake after sleep onset
Total time of epochs staged as "wake" after sleep latency.
Immediately after the polysomnography.
Latency to REM sleep
Time from sleep latency until the first epoch of REM sleep.
Immediately after the polysomnography.
Total time for each sleep stage
Time corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM)
Immediately after the polysomnography.
Percentage each sleep stage
Percentage corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM), in comparison with total sleep time.
Immediately after the polysomnography.
Study Arms (2)
Healthy participants
Participants from 20 to 80 years old, from both genders and with no sleep disorders
Participants with sleep disorders
Participants between the ages of 20 and 80 years who reported one or more sleep-related disorders or complaints. 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).
Interventions
Combination of ACT+EEG. This is not an intervention, but rather a combination of devices to be tested regarding its diagnostic validity.
Eligibility Criteria
Individuals from both genders, from 20 to 80 years old, healthy (at stage 1) or with at least one sleep disoder or complaint (at stage 2).
You may qualify if:
- 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.
You may not qualify if:
- 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)
- 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).
- Absence of sleep disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
SleepUp Tecnologia em Saúde LTDA
São Caetano do Sul, São Paulo, 09530-250, Brazil
Centro de Especialistas do Sono
São Paulo, 01416-001, Brazil
Related Publications (1)
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: 38427322DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Pires, PhD
Instituto do Sono
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2021
First Posted
June 29, 2021
Study Start
September 9, 2021
Primary Completion
December 12, 2021
Study Completion (Estimated)
December 1, 2026
Last Updated
December 2, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
The dissemination of Individual Participant Data (IPD) from this study is strictly limited by restrictions on the release of intellectual property, concerns regarding participant privacy and confidentiality, and the absence of explicit consent for extensive data sharing. However, upon reasonable request and subject to approval by the study's principal investigator, anonymized datasets may be provided to qualified researchers. It is imperative that requests include a thorough research proposal and a rationale that substantiates the need for the resources in question.