Validation Study of a Patch-based PSG System

Sleep Disorder Clinical Trial

Official title:

Validation Study of a Patch-based PSG System

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05310708
• Other study ID #: CIP_Protocol_Onera_R01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: June 21, 2024

Study information

• Verified date: April 2024
• Source: Onera BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: June 21, 2024
• Est. primary completion date: June 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
Germany	Schlaf- u. Beatmungszentrum Ulm/Blaubeuren	Blaubeuren
Germany	Evang. Kliniken Essen-Mitte	Essen
Germany	Ruhrlandklinik, Zentrum für Schlaf- und Telemedizin	Essen
Germany	American Sleep Clinic	Frankfurt	Frankfurt Am Main
Germany	VAMED Klinik Hagen-Ambrock	Hagen
Germany	Universitätsklinikum Giessen und Marburg	Marburg
Germany	Krankenhaus Bethanien	Solingen

Sponsors (1)

Lead Sponsor	Collaborator
Onera BV

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Snoring	Snoring is measured with the microphone imbedded in the sensor on the chest and expressed in Decibel[dB].	1 year
Primary	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
Primary	Nasal Cannula Flow	The Nasal Cannula Flow is measured on the belly using a cannula (expressed: [mmH2O]).	1 year
Primary	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	Total Sleep Time	The total time spend asleep expressed in minutes or hours.	1 year
Secondary	Time In Bed	The total time spend in bed expressed in minutes or hours.	1 year
Secondary	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
Secondary	Wake Time	The total time spend awake expressed in minutes or hours.	1 year
Secondary	Time in N1	The total time spend in the N1 sleep stage, expressed in minutes or hours.	1 year
Secondary	Time in N2	The total time spend in the N2 sleep stage, expressed in minutes or hours.	1 year
Secondary	Time in N3	The total time spend in the N3 sleep stage, expressed in minutes or hours.	1 year
Secondary	Time in REM	The total time spend in the Rapid Eye Movement (REM) sleep stage, expressed in minutes or hours.	1 year
Secondary	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
Secondary	REM	Amount of time spend in the Rapid Eye Movement (REM) sleep stage, expressed in percentage [%].	1 year
Secondary	NREM	Amount of time spend in the Non Rapid Eye Movement (NREM) sleep stage, expressed in percentage [%].	1 year
Secondary	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
Secondary	WASO	Wake After Sleep Onset (WASO) measures wakefulness, excluding the wakefulness occurring before sleep onset, and is expressed in minutes or hours.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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