Sleep StagingNCT07099183
Nyx3 Data Collection Study
An observational study of Sleep Staging, run by ResMed.
Trial summary
Each participant will wear the Nyx3 eye mask and Hypnodyne headband for 1 night at-home. Objectives include collecting and evaluating data quality from the Nyx3 eye mask, and exploring the impact of its paced breathing feature on sleep onset latency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Staging
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2025to 1 Oct 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be healthy adult volunteers, aged 18 or above, with self-reported normal sleep patterns. The study population will include a diverse sample across age, sex, race, and ethnicity. Recruitment strategies will include outreach to both internal and external community participants to ensure a broad representation.
Who may be able to join
- Participants willing to give written informed consent
- Participants who ≥ 18 years of age
- Participants who can trial the eye mask overnight
Who cannot join
- Participants with active medical implants that interact with magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps).
- Participants with metallic implants/objects containing ferromagnetic material (i.e., aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye)
- Participants who are or may be pregnant
- Participants who are currently enrolled in other clinical studies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Alisha Middleton, BSc (Sport & Exercise Science) contact
About this study
Official title: Nyx3 Eye Mask Physiological Data Collection Study
Each participant will wear the Nyx3 eye mask and Hypnodyne headband for 1 night at-home. Objectives include collecting and evaluating data quality from the Nyx3 eye mask, and exploring the impact of its paced breathing feature on sleep onset latency.
Read the detailed description
The Nyx3 data collection study evaluates the Nyx3 EEG eye mask, a wearable device designed to collect EEG data for sleep staging. Traditional sleep diagnostics via polysomnography (PSG) are resource-intensive and limited to clinical settings. This study addresses the need for scalable, home-based, non-invasive sleep monitoring solutions by collecting data for algorithm development and validating the Nyx3 device's feasibility and performance against the Hypnodyne headband-a validated wearable EEG comparator.
60 participants who meet the inclusion criteria will perform the following: Visit 1 Participants will provide written informed consent. Participants will be shown the Nyx3 eye mask and Hypnodyne and shown how to use them and trial them for fit and comfort. If the participant and assessor are happy to proceed, the participants will take the eye mask home to trial.
Visit 2 The participant will return the Nyx3 eye mask to the assessor. The participants' questionnaire responses will be reviewed. This concludes participation in the study.
- Conditions
- Sleep Staging
- Keywords
- EEG, Sleep Eye Mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nyx3 and Hypnodyne EEG and accelorometer data collection | Participants will use both the Nyx3 eye mask and Hypnodyne headband concurrently in a real-world home sleep environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep-related EEG and accelerometry data
The primary endpoint of this study is to evaluate the performance of the Nyx3 eye mask in capturing sleep-related EEG and accelerometry data suitable for automated sleep staging (Night-level summary statistics-such as total sleep time (TST), sleep onset latency (SOL), and percentage time spent in each sleep stage (e.g., %REM, %N3)), and to compare its signal quality and staging outputs against a validated comparator device, the Hypnodyne headband Nyx3. In this study, the primary endpoint is the agreement between the Nyx3 and Hypnodyne sleep-stage labels, which will be captured using Cohen's κ.
Measured: Day 1
Secondary outcomes (1)
Subjective sleep latency
The secondary endpoint of this study is to explore whether the use of the paced breathing feature within the Nyx3 EEG eye mask is associated with subjective reduced sleep onset latency (SOL) and/or improved subjective sleep quality.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start30 Jul 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep StagingStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alison Wimms, PhD, Principal investigator, ResMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099183
- Sponsor's protocol ID
- SLP-25-06-01
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nyx3 Eye Mask Physiological Data Collection Study
- ClinicalTrials.gov ID
- NCT07099183
- Acronym / sponsor ID
- SLP-25-06-01
- Conditions
- Sleep Staging
- Keywords
- EEG, Sleep Eye Mask
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 1 Aug 2025 (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.
Each participant will wear the Nyx3 eye mask and Hypnodyne headband for 1 night at-home. Objectives include collecting and evaluating data quality from the Nyx3 eye mask, and exploring the impact of its paced breathing feature on sleep onset latency.
Detailed description
The Nyx3 data collection study evaluates the Nyx3 EEG eye mask, a wearable device designed to collect EEG data for sleep staging. Traditional sleep diagnostics via polysomnography (PSG) are resource-intensive and limited to clinical settings. This study addresses the need for scalable, home-based, non-invasive sleep monitoring solutions by collecting data for algorithm development and validating the Nyx3 device's feasibility and performance against the Hypnodyne headband-a validated wearable EEG comparator.
60 participants who meet the inclusion criteria will perform the following: Visit 1 Participants will provide written informed consent. Participants will be shown the Nyx3 eye mask and Hypnodyne and shown how to use them and trial them for fit and comfort. If the participant and assessor are happy to proceed, the participants will take the eye mask home to trial.
Visit 2 The participant will return the Nyx3 eye mask to the assessor. The participants' questionnaire responses will be reviewed. This concludes participation in the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nyx3 and Hypnodyne EEG and accelorometer data collection | – | –Participants will use both the Nyx3 eye mask and Hypnodyne headband concurrently in a real-world home sleep environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be healthy adult volunteers, aged 18 or above, with self-reported normal sleep patterns. The study population will include a diverse sample across age, sex, race, and ethnicity. Recruitment strategies will include outreach to both internal and external community participants to ensure a broad representation.
Key inclusion criteria (3 listed)
- Participants willing to give written informed consent
- Participants who ≥ 18 years of age
- Participants who can trial the eye mask overnight
Key exclusion criteria (4 listed)
- Participants with active medical implants that interact with magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps).
- Participants with metallic implants/objects containing ferromagnetic material (i.e., aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye)
- Participants who are or may be pregnant
- Participants who are currently enrolled in other clinical studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sleep-related EEG and accelerometry data
Time frame: Day 1
The primary endpoint of this study is to evaluate the performance of the Nyx3 eye mask in capturing sleep-related EEG and accelerometry data suitable for automated sleep staging (Night-level summary statistics-such as total sleep time (TST), sleep onset latency (SOL), and percentage time spent in each sleep stage (e.g., %REM, %N3)), and to compare its signal quality and staging outputs against a validated comparator device, the Hypnodyne headband Nyx3. In this study, the primary endpoint is the agreement between the Nyx3 and Hypnodyne sleep-stage labels, which will be captured using Cohen's κ.
1 secondary outcome
Subjective sleep latency
Time frame: Baseline
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 1 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Alisha Middleton, BSc (Sport & Exercise Science) contact
Alison Wimms, PhD principal investigator
ResMed
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Staging, run by ResMed.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Alisha Middleton, BSc (Sport & Exercise Science) (+61 2 88842620, alisha.middleton@resmed.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep-related EEG and accelerometry data (time frame: Day 1). 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 1 Aug 2025.