Nyx3 Data Collection Study

NCT07099183 | Not Yet Recruiting DMC

• 1 other identifier: SLP-25-06-01
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sleep Staging

Keywords

EEG; Sleep Eye Mask

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (1)

• Subjective sleep latency

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Participants willing to give written informed consent
• Participants who ≥ 18 years of age
• Participants who can trial the eye mask overnight

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Officials

• Alison Wimms, PhD

  ResMed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisha Middleton, BSc (Sport & Exercise Science)

CONTACT

+61 2 88842620; alisha.middleton@resmed.com.au

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: August 1, 2025
• Study Start: July 30, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share