SleepNCT04943562
Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging
An observational study of Sleep and Insomnia, run by SleepUp Tecnologia em Saúde Ltda at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Sleep, Insomnia, Sleep Apnea Syndrome, Obstructive
- What is being tested?
- ACT+EEG
- How many people
- 96 participants
- Where
- 2 sitesBrazil
- Study dates
- 9 Sep 2021to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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.
- 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).
Who cannot join
- 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)
Show all 11Show fewer
- 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)
- Absence of sleep disorders.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Recruiting
SleepUp Tecnologia em Saúde LTDA
São Caetano do Sul, São Paulo, 09530-250
Renata Bonaldi, PhD, +55 11 95555-6467, renata.bonaldi@sleepup.com.br
- Recruiting
Centro de Especialistas do Sono
São Paulo, 01416-001
Centro de Especialistas do Sono, 11 98926-4530, especialistasdosono@gmail.com
About this study
Official title: Evaluation of the Viability of Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging in Comparison With Polysomnography
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:
Read more
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.
Read the detailed 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: 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.
- Conditions
- Sleep, Insomnia, Sleep Apnea Syndrome, Obstructive
- Being tested
- ACT+EEG
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT+EEGDiagnostic test
Combination of ACT+EEG. This is not an intervention, but rather a combination of devices to be tested regarding its diagnostic validity.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Participants from 20 to 80 years old, from both genders and with no sleep disorders Receives: Diagnostic Test: ACT+EEG | |
| 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). Receives: Diagnostic Test: ACT+EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Latency
Time from the beginning of the polysomnographic record until the first epoch of sleep.
Measured: Immediately after the polysomnography.
Total sleep time
Total time of epochs staged as sleep.
Measured: Immediately after the polysomnography.
Sleep efficiency
Percentage of sleep in relation to total record/bed time.
Measured: Immediately after the polysomnography.
Wake after sleep onset
Total time of epochs staged as "wake" after sleep latency.
Measured: Immediately after the polysomnography.
Latency to REM sleep
Time from sleep latency until the first epoch of REM sleep.
Measured: 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)
Measured: 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.
Measured: Immediately after the polysomnography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start9 Sep 2021
- Primary completion12 Dec 2021
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SleepUp Tecnologia em Saúde Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriel Pires, PhD, Principal investigator, Instituto do Sono
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943562
- Sponsor's protocol ID
- SleepUp_#02
- Status last verified
- Nov 2025
- First submitted
- 13 Jun 2021
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38427322
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Viability of Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging in Comparison With Polysomnography
- ClinicalTrials.gov ID
- NCT04943562
- Acronym / sponsor ID
- SleepUp_#02
- Conditions
- Sleep, Insomnia, Sleep Apnea Syndrome, Obstructive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- SleepUp Tecnologia em Saúde LtdaIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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: 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Diagnostic Test: ACT+EEGParticipants from 20 to 80 years old, from both genders and with no sleep disorders |
| Participants with sleep disorders | – | Diagnostic Test: ACT+EEGParticipants 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). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (7 listed)
- 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.
- Age between 20 and 80 years old
- Living in the city of São Paulo, Brazil
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT+EEGCombination of ACT+EEG. This is not an intervention, but rather a combination of devices to be tested regarding its diagnostic validity. | Diagnostic test | Healthy participants, Participants with sleep disorders |
Primary outcome
Sleep Latency
Time frame: Immediately after the polysomnography.
Time from the beginning of the polysomnographic record until the first epoch of sleep.
Total sleep time
Time frame: Immediately after the polysomnography.
Total time of epochs staged as sleep.
Sleep efficiency
Time frame: Immediately after the polysomnography.
Percentage of sleep in relation to total record/bed time.
Wake after sleep onset
Time frame: Immediately after the polysomnography.
Total time of epochs staged as "wake" after sleep latency.
Latency to REM sleep
Time frame: Immediately after the polysomnography.
Time from sleep latency until the first epoch of REM sleep.
Total time for each sleep stage
Time frame: Immediately after the polysomnography.
Time corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM)
Percentage each sleep stage
Time frame: Immediately after the polysomnography.
Percentage corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM), in comparison with total sleep time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Derived from this study: PubMed 38427322Melo 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriel Pires, PhD principal investigator
Instituto do Sono
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Insomnia, run by SleepUp Tecnologia em Saúde Ltda at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renata Bonaldi, PhD (+55 11 933191375, pesquisa@sleepup.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Latency (time frame: Immediately after the polysomnography.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.