SleepNCT06237842
Wearable Technologies for Sleep in Children and Adolescents
An observational study of Sleep and Pediatric Sleep Apnea, run by SleepUp Tecnologia em Saúde Ltda at 1 site in Brazil.
Trial summary
This study aims to evaluate the viability of wearable and portable technologies for sleep staging in children and adolescents. 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 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Pediatric Sleep Apnea
- What is being tested?
- Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT)
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Nov 2024to 1 May 2027
- How long will I take part?
- 1 Day
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children/adolescents who come to the Sleep Laboratory of the Children's Institute of the University of São Paulo for a polysomnography test.
Who may be able to join
- All genders
- 3 to 18 years olnde
- Resident in the city of São Paulo
- Candidate to perfome a polysomnography test at the Sleep Laboratory of the Children's Institute of the Hospital das Clínicas of the University of São Paulo.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto da Criança do Hospital da Clínicas - FMUSP
São Paulo, São Paulo, 05403-000
Leticia Soster, PhD, +55 11 2661-8500, sonoinfantilicr@gmail.com
Anna Monazzi, +55 11 2661-8500, sonoinfantilicr@gmail.com
About this study
Official title: Evaluation of Wearable Technologies for Sleep Monitoring in Children and Adolescents
This study aims to evaluate the viability of wearable and portable technologies for sleep staging in children and adolescents. 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 pulse oximetry.
The project will include individuals between the ages of 3 and 18 who reside in São Paulo city and undergo a polysomnography test at the Sleep Laboratory of the Children's Institute of the Hospital das Clínicas of the University of São Paulo.
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.
- Wearable EEG band: EEG is a mandatory feature for type-1 polysomnography and a requirement for regular sleep staging. The project will utilize a wearable EEG band in combination with actigraphy and a ring oximeter to improve the estimation of sleep stages. This study will test wearable EEG bands with the following minimal specifications: dry EEG electrodes (no need for paste, gel, or other conductors), presented as a headband or stripe, a minimal sampling rate of 500Hz, noise, high and low filters, a battery lasting at least 8 hours, a maximum weight of 200g (including the whole device), and support for Bluetooth connection.
- Ring oximeter: The project will utilize a ring oximter to record the overnight blood oxygen levels, heart rates, and body movements.
- Conditions
- Sleep, Pediatric Sleep Apnea
- Being tested
- Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT)
- Keywords
- Pediatric sleep, Adolescent sleep, EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT)Diagnostic test
Combination of ACT+RO+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 3 to 18 years old, from both genders and with no sleep disorders Receives: Diagnostic Test: Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT) | |
| Participants with sleep disorders | Participantes with one sleep disorder or complaint. Receives: Diagnostic Test: Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT) |
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 posted2 Feb 2024
- Study start22 Nov 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 48 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- SleepUp Tecnologia em Saúde Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leticia Soster, PhD, Principal investigator, Instituto da Criança do Hospital da Clínicas- FMUSPAnna Monazzi, PhD, Study director, Instituto da Criança do Hospital da Clínicas- FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237842
- Sponsor's protocol ID
- SleepUp_#03
- Status last verified
- Nov 2025
- First submitted
- 23 Jan 2024
- 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.
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 Wearable Technologies for Sleep Monitoring in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06237842
- Acronym / sponsor ID
- SleepUp_#03
- Conditions
- Sleep, Pediatric Sleep Apnea
- Keywords
- Pediatric sleep, Adolescent sleep, EEG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- SleepUp Tecnologia em Saúde LtdaIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 2 Feb 2024 (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 wearable and portable technologies for sleep staging in children and adolescents. 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 pulse oximetry.
The project will include individuals between the ages of 3 and 18 who reside in São Paulo city and undergo a polysomnography test at the Sleep Laboratory of the Children's Institute of the Hospital das Clínicas of the University of São Paulo.
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.
- Wearable EEG band: EEG is a mandatory feature for type-1 polysomnography and a requirement for regular sleep staging. The project will utilize a wearable EEG band in combination with actigraphy and a ring oximeter to improve the estimation of sleep stages. This study will test wearable EEG bands with the following minimal specifications: dry EEG electrodes (no need for paste, gel, or other conductors), presented as a headband or stripe, a minimal sampling rate of 500Hz, noise, high and low filters, a battery lasting at least 8 hours, a maximum weight of 200g (including the whole device), and support for Bluetooth connection.
- Ring oximeter: The project will utilize a ring oximter to record the overnight blood oxygen levels, heart rates, and body movements.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Diagnostic Test: Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT)Participants from 3 to 18 years old, from both genders and with no sleep disorders |
| Participants with sleep disorders | – | Diagnostic Test: Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT)Participantes with one sleep disorder or complaint. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children/adolescents who come to the Sleep Laboratory of the Children's Institute of the University of São Paulo for a polysomnography test.
Key inclusion criteria (4 listed)
- All genders
- 3 to 18 years olnde
- Resident in the city of São Paulo
- Candidate to perfome a polysomnography test at the Sleep Laboratory of the Children's Institute of the Hospital das Clínicas of the University of São Paulo.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT)Combination of ACT+RO+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.
- 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.
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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.
Leticia Soster, PhD principal investigator
Instituto da Criança do Hospital da Clínicas- FMUSP
Anna Monazzi, PhD study director
Instituto da Criança do Hospital da Clínicas- FMUSP
1 site 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 Pediatric Sleep Apnea, run by SleepUp Tecnologia em Saúde Ltda at 1 site 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 4 inclusion and 1 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 1 site 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 Leticia Soster, PhD (+55 11 2661-8500, sonoinfantilicr@gmail.com), 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?
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.