Nyx3 Data Collection Study

NCT ID: NCT07099183

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2025-10-01

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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison Wimms, PhD

Role: PRINCIPAL_INVESTIGATOR

ResMed

Central Contacts

Alisha Middleton, BSc (Sport & Exercise Science)

Role: CONTACT

alisha.middleton@resmed.com.au

+61 2 88842620

Other Identifiers

SLP-25-06-01

Identifier Type: -

Identifier Source: org_study_id