Nyx3 Data Collection Study

ConditionSleep Staging

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorResMed

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants willing to give written informed consent

Participants who ≥ 18 years of age

Participants who can trial the eye mask overnight

Disqualifiers

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 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants

are grouped into 1 trial group

Group A: Nyx3 and Hypnodyne EEG and accelorometer data collection

Trial outcomes

Primary outcomes

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.

Time frame

Day 1

Secondary outcomes

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.

Time frame

Baseline

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ResMed

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: