Validation Study of a Patch-based PSG System

Study Overview
=================
Brief Summary
-----------------
This study is a study that qualifies as other clinical investigation under Art. 82 MDR and §47 Abs. 3 MPDG with a CE-marked device that aims to demonstrate that the physiological signals from the Onera STS system are substantially equivalent to physiological systems recorded by traditional PSG systems. Furthermore, the study aims to identify the proportion of users who can successfully perform an overnight Onera STS study in an unsupervised home setting. The Onera STS will be used within its approved indication, and the study participants will not be subjected to additional invasive or burdensome procedures.

Official Title
-----------------
Validation Study of a Patch-based PSG System

Conditions
-----------------
Sleep Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Either referral for a suspected sleep disorder requiring a sleep diagnostic study, or, An already diagnosed sleep disorder requiring a planned follow-up PSG. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Validation Study of a patch-based PSG system<br>Measuring and recording multiple physiological parameters from a patient which are used by clinicians to make a decision on the diagnosis of sleep. | Diagnostic Test: Polysomnography<br>* Measuring and recording multiple physiological parameters from a patient which are used by clinicians to make a decision on the diagnosis of sleep.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EOG left | Electrooculogram (EOG) is measured on the left side. Here, electrical activity of the eye is measured with an electrode and expressed in microvolt[uV]. | 1 year | 
| EOG right | Electrooculogram (EOG) is measured on the right side. Here, electrical activity of the eye is measured with an electrode and expressed in microvolt[uV]. | 1 year | 
| EEG left | Electroencephalogram (EEG) is measured on the left side. Here, electrical activity of the brain is measured with an electrode and expressed in microvolt[uV]. | 1 year | 
| EEG right | Electroencephalogram (EEG) is measured on the right side. Here, electrical activity of the brain is measured with an electrode and expressed in microvolt[uV]. | 1 year | 
| EMG left | Electromyogram (EMG) is measured on the left side. Here, electrical activity of the muscle is measured with an electrode and expressed in microvolt[uV]. | 1 year | 
| EMG right | Electromyogram (EMG) is measured on the right side. Here, electrical activity of the muscle is measured with an electrode and expressed in microvolt[uV]. | 1 year | 
| SpO2 | Oxygen Saturation (SpO2) is derived from red and infrared Photoplethysmography (PPG) which is measured on the forehead with a reflective pulse oximetry sensor. | 1 year | 
| ECG | Electrocardiogram (ECG) is measured on the chest. Here, electrical activity of the heart is measured with an electrode and expressed in microvolt[mV]. | 1 year | 
| BioZ Flow | Respiratory Flow (BioZ Flow) is derived from the bioimpedance which is measured on the chest with an electrode (expressed: [a.u.]). | 1 year | 
| BioZ Effort | Respiratory Effort (BioZ Effort) is derived from the bioimpedance which is measured on the chest with an electrode (expressed: [a.u.]). | 1 year | 
| Activity | The activity is derived from the accelerometer data of the x, y, and z axis, which is measured on the chest and expressed in the gravitational force equivalent[g]. | 1 year | 
| Snoring | Snoring is measured with the microphone imbedded in the sensor on the chest and expressed in Decibel[dB]. | 1 year | 
| Body Position | The body Position is derived from the accelerometer data of the x, y, and z axis, which is measured on the chest and expressed in degrees[deg]. | 1 year | 
| Nasal Cannula Flow | The Nasal Cannula Flow is measured on the belly using a cannula (expressed: [mmH2O]). | 1 year | 
| EMG Leg | Electromyogram (EMG) is measured on the lower leg. Here, electrical activity of the muscle is measured with an electrode and expressed in microvolt[mV]. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | The total time spend asleep expressed in minutes or hours. | 1 year | 
| Time In Bed | The total time spend in bed expressed in minutes or hours. | 1 year | 
| SOL | Sleep Onset Latency (SOL) is the length of time that it takes to accomplish the transition from full wakefulness to sleep, expressed in minutes or hours. | 1 year | 
| Wake Time | The total time spend awake expressed in minutes or hours. | 1 year | 
| Time in N1 | The total time spend in the N1 sleep stage, expressed in minutes or hours. | 1 year | 
| Time in N2 | The total time spend in the N2 sleep stage, expressed in minutes or hours. | 1 year | 
| Time in N3 | The total time spend in the N3 sleep stage, expressed in minutes or hours. | 1 year | 
| Time in REM | The total time spend in the Rapid Eye Movement (REM) sleep stage, expressed in minutes or hours. | 1 year | 
| Time in NREM | The total time spend in the Non Rapid Eye Movement (NREM), which contains of the N1, N2, N3 sleep stages, expressed in minutes or hours. | 1 year | 
| REM | Amount of time spend in the Rapid Eye Movement (REM) sleep stage, expressed in percentage [%]. | 1 year | 
| NREM | Amount of time spend in the Non Rapid Eye Movement (NREM) sleep stage, expressed in percentage [%]. | 1 year | 
| REM Onset Latency | The elapsed time between sleep onset and the onset of the first Rapid Eye Movement (REM) sleep period, expressed in minutes or hours. | 1 year | 
| WASO | Wake After Sleep Onset (WASO) measures wakefulness, excluding the wakefulness occurring before sleep onset, and is expressed in minutes or hours. | 1 year | 
| AI | The Arousal Index (AI) divides the total number of arousals by the number of hours of sleep, and therefore is an index for the sleep quality. The lower this amount, the better the outcome. | 1 year | 
| AHI | The Apnea Hypopnea Index (AHI) is the total amount of apnea or hypopnea event per hour of sleep, and therefore is an index for the severity of sleep apnea. The lower this amount, the better the outcome. | 1 year | 
| SpO2 | Oxygen Saturation (SpO2) is derived from red and infrared Photoplethysmography (PPG) which is measured on the forehead with a reflective pulse oximetry sensor. This will be expressed in the mean, the minimum, and the maximum. | 1 year | 
| ODI | The Oxygen Desaturation Index (ODI) is the amount of times per hour of sleep that your blood oxygen level drops by 3% from baseline. The lower this amount the better the outcome. | 1 year | 
| HR | Heart Rate (HR) is the number of times the heart beats per minute, is derived from the Electrocardiogram (ECG), and expressed in beats per minute[bpm]. | 1 year | 
| Set-up Time PSG (not applicable for application in unsupervised home setting) | Comparison of the setup time (fitting and activation) between the Onera STS system and a traditional Polysomnography (PSG) system. | 1 year |