Validation Study of a Patch-based PSG System

April 5, 2024 updated by: Onera BV
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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
EOG left
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
Respiratory Effort (BioZ Effort) is derived from the bioimpedance which is measured on the chest with an electrode (expressed: [a.u.]).
1 year
Activity
Time Frame: 1 year
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
Time Frame: 1 year
Snoring is measured with the microphone imbedded in the sensor on the chest and expressed in Decibel[dB].
1 year
Body Position
Time Frame: 1 year
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
Time Frame: 1 year
The Nasal Cannula Flow is measured on the belly using a cannula (expressed: [mmH2O]).
1 year
EMG Leg
Time Frame: 1 year
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Sleep Time
Time Frame: 1 year
The total time spend asleep expressed in minutes or hours.
1 year
Time In Bed
Time Frame: 1 year
The total time spend in bed expressed in minutes or hours.
1 year
SOL
Time Frame: 1 year
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
Time Frame: 1 year
The total time spend awake expressed in minutes or hours.
1 year
Time in N1
Time Frame: 1 year
The total time spend in the N1 sleep stage, expressed in minutes or hours.
1 year
Time in N2
Time Frame: 1 year
The total time spend in the N2 sleep stage, expressed in minutes or hours.
1 year
Time in N3
Time Frame: 1 year
The total time spend in the N3 sleep stage, expressed in minutes or hours.
1 year
Time in REM
Time Frame: 1 year
The total time spend in the Rapid Eye Movement (REM) sleep stage, expressed in minutes or hours.
1 year
Time in NREM
Time Frame: 1 year
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
Time Frame: 1 year
Amount of time spend in the Rapid Eye Movement (REM) sleep stage, expressed in percentage [%].
1 year
NREM
Time Frame: 1 year
Amount of time spend in the Non Rapid Eye Movement (NREM) sleep stage, expressed in percentage [%].
1 year
REM Onset Latency
Time Frame: 1 year
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
Time Frame: 1 year
Wake After Sleep Onset (WASO) measures wakefulness, excluding the wakefulness occurring before sleep onset, and is expressed in minutes or hours.
1 year
AI
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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)
Time Frame: 1 year
Comparison of the setup time (fitting and activation) between the Onera STS system and a traditional Polysomnography (PSG) system.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Onera BV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hartmut Schneider, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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