Validation Study of a Patch-based PSG System

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sleep Disorder
• Intervention / Treatment: Diagnostic test: Polysomnography

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Blaubeuren, Germany, 89143
    • Schlaf- u. Beatmungszentrum Ulm/Blaubeuren
  • Essen, Germany, 45239
    • Ruhrlandklinik, Zentrum für Schlaf- und Telemedizin
  • Essen, Germany, 45276
    • Evang. Kliniken Essen-Mitte
  • Hagen, Germany, 58091
    • VAMED Klinik Hagen-Ambrock
  • Marburg, Germany, 35043
    • Universitätsklinikum Giessen und Marburg
  • Solingen, Germany, 42699
    • Krankenhaus Bethanien
  • Frankfurt Am Main
    • Frankfurt, Frankfurt Am Main, Germany, 60389
      • American Sleep Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Onera BV
• Investigators: Principal Investigator: Hartmut Schneider, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Estimated): June 21, 2024
• Study Completion (Estimated): June 21, 2024

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: CIP_Protocol_Onera_R01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pseudonymized datasets and 2D images will be shared with Onera for analysis using secure data transfer. Any images of the facial region will have distinguishing features redacted prior to transfer. Pseudonymized PSG and Onera STS studies (raw and scored) will also be shared with Onera. Following transfer, all study data will be stored on a password protected computer and will only be made available to Onera employees who plan to process it in a way that is compatible with the purposes for which it was collected.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No