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

NCT ID: NCT06881667

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-04
• Study Completion Date: 2024-09-02

Brief 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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Home PSG Assessment

Testing of the Onera STS in the home environment with the current device shipment method and instructions.

Group Type: EXPERIMENTAL

Home PSG Assessment

Intervention Type: DEVICE

Testing of the Onera STS in the home environment with the current device shipment method and instructions.

Interventions

Home PSG Assessment

Testing of the Onera STS in the home environment with the current device shipment method and instructions.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years and older
• Referral for a suspected sleep disorder requiring a sleep diagnostic study

Exclusion Criteria

• Inability to provide informed consent
• History of allergic reactions to adhesives or hydrogels or a family history of adhesive skin allergies
• Severe skin condition at sites of patch administration such as wounds, burns or on any damaged skin
• Has an implanted cardiac stimulator or diaphragmatic pacer
• Has an anatomical abnormality that, in the opinion of the Principal Investigator, makes the subject ineligible for inclusion
• Will be exposed to high-frequency surgical equipment, near strong magnetic fields or with devices such as MRIs, external cardiac stimulators during their use of the Onera device

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Onera BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

Clayton Sleep Institute

St Louis, Missouri, United States

Countries

United States

References

Uhles M, Alisic S, Brown A, Doekel R, Booth W, Ojile J. Feasibility and acceptance of self-applied home type-II PSG studies with a patch-based device. Sleep Breath. 2025 Oct 28;29(6):336. doi: 10.1007/s11325-025-03503-z.

Reference Type: DERIVED

PMID: 41148462 (View on PubMed)

Other Identifiers

CIP_Protocol_Onera_D01

Identifier Type: -

Identifier Source: org_study_id