NCT06881667

US Development and Evaluation Study of a Patch-Based PSG System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Onera BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.

Detailed description

The diagnostic gold standard to detect a sleep disorder in the presence of a comorbidity is attended, inpatient, polysomnography (PSG)1. Currently, these tests are limited to the in-patient setting in the sleep laboratory, which requires a large number of personnel, and the PSG studies are time-consuming and expensive to conduct. PSG studies are also burdensome for patients, as they require each patient to sleep at the hospital for at least one night while wearing multiple electrodes and other physiological monitoring equipment attached to the head, face, torso, and legs, which makes sleeping difficult and limits movement. A portable PSG device that does not incorporate traditional leads and electrodes would facilitate sleep studies and allow such studies to be done in other locations and be performed more quickly and easily. Studies outside the hospital setting using an optimized, portable PSG device would be easier for sleep technicians to set up and allow each patient to sleep more comfortably. Onera STS is a wearable system for measuring physiological signals during a PSG study that was designed to overcome the limitations described above that are associated with attended, inpatient PSG. The Onera STS performs electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), and electrocardiography (ECG) and also measures respiratory signals, nasal pressure, oxygen saturation, activity, body position, and snoring loudness via four sensor patches applied to the forehead, upper chest, abdomen, and lower leg. These sensor patches eliminate the need for individual leads and separate electrodes. When used in an in-patient setting, setup time can be reduced compared to the classical PSG setup. The Onera STS system is FDA approved (510k) for the purpose of monitoring physiological parameters intended to provide information which is used to take decisions on the diagnosis of sleep disorders. The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.

Conditions

• Sleep Disorder (Disorder)

Interventions

Type	Name	Description
DEVICE	Home PSG Assessment	Testing of the Onera STS in the home environment with the current device shipment method and instructions.

Timeline

• Start date: 2023-08-04
• Primary completion: 2024-09-02
• Completion: 2024-09-02
• First posted: 2025-03-18
• Last updated: 2025-03-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study