Validation Study of a Patch-based PSG System

NCT05310708 | Enrolling By Invitation

• 1 other identifier: CIP_Protocol_Onera_R01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

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.

Conditions

Sleep Disorder

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (19)

• Total Sleep Time

  1 year

• Time In Bed

  1 year

• SOL

  1 year

• Wake Time

  1 year

• Time in N1

  1 year

Study Arms (1)

Validation Study of a patch-based PSG system

EXPERIMENTAL

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

Interventions

Polysomnography DIAGNOSTIC_TEST

Measuring and recording multiple physiological parameters from a patient which are used by clinicians to make a decision on the diagnosis of sleep.

Validation Study of a patch-based PSG system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Onera BV: lead

Study Sites (7)

American Sleep Clinic

Frankfurt, Frankfurt Am Main, 60389, Germany

Location

Schlaf- u. Beatmungszentrum Ulm/Blaubeuren

Blaubeuren Abbey, 89143, Germany

Location

Ruhrlandklinik, Zentrum für Schlaf- und Telemedizin

Essen, 45239, Germany

Location

Evang. Kliniken Essen-Mitte

Essen, 45276, Germany

Location

VAMED Klinik Hagen-Ambrock

Hagen, 58091, Germany

Location

Universitätsklinikum Giessen und Marburg

Marburg, 35043, Germany

Location

Krankenhaus Bethanien

Solingen, 42699, Germany

Location

Related Publications (1)

• Viniol C, Galetke W, Woehrle H, Nilius G, Schobel C, Randerath W, Leiter J, Canisius S, Schneider H. Clinical validation of a wireless patch-based polysomnography system. J Clin Sleep Med. 2025 May 1;21(5):813-823. doi: 10.5664/jcsm.11524.

  PMID: 39773950 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hartmut Schneider

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: April 5, 2022
• Study Start: January 21, 2022
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (7)