Clinical trial NCT06881667: US Development and Evaluation Study of a Patch-Based PSG System
Official title: US Development and Evaluation Study of a Patch-Based PSG System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder (Disorder)
Keywords: sleep disordered breathing
sdb
sleep apnea
obstructive sleep apnea
apnea
home PSG
PSG
PSG type 2
PSG type II
sleep diagnostics
home
Lead sponsor: Onera BV
Sponsor class: INDUSTRY
First posted: 2025-03-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Study Success Rate
timeFrame: Assessment will be completed within one month after completion of the sleep study.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Sleep Disorders Center of Alabama
state: Alabama
city: St. Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
Study officials:
References: