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Validation Study of a Patch-based PSG System

Primary Purpose

Sleep Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Polysomnography
Sponsored by
Onera BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • American Sleep Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Validation Study of a patch-based PSG system

Arm Description

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

Outcomes

Primary Outcome Measures

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].
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].
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].
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].
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].
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].
SpO2
Oxygen Saturation (SpO2) is derived from red and infrared Photoplethysmography (PPG) which is measured on the forehead with a reflective pulse oximetry sensor.
ECG
Electrocardiogram (ECG) is measured on the chest. Here, electrical activity of the heart is measured with an electrode and expressed in microvolt[mV].
BioZ Flow
Respiratory Flow (BioZ Flow) is derived from the bioimpedance which is measured on the chest with an electrode (expressed: [a.u.]).
BioZ Effort
Respiratory Effort (BioZ Effort) is derived from the bioimpedance which is measured on the chest with an electrode (expressed: [a.u.]).
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].
Snoring
Snoring is measured with the microphone imbedded in the sensor on the chest and expressed in Decibel[dB].
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].
Nasal Cannula Flow
The Nasal Cannula Flow is measured on the belly using a cannula (expressed: [mmH2O]).
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].

Secondary Outcome Measures

Total Sleep Time
The total time spend asleep expressed in minutes or hours.
Time In Bed
The total time spend in bed expressed in minutes or hours.
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.
Wake Time
The total time spend awake expressed in minutes or hours.
Time in N1
The total time spend in the N1 sleep stage, expressed in minutes or hours.
Time in N2
The total time spend in the N2 sleep stage, expressed in minutes or hours.
Time in N3
The total time spend in the N3 sleep stage, expressed in minutes or hours.
Time in REM
The total time spend in the Rapid Eye Movement (REM) sleep stage, expressed in minutes or hours.
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.
REM
Amount of time spend in the Rapid Eye Movement (REM) sleep stage, expressed in percentage [%].
NREM
Amount of time spend in the Non Rapid Eye Movement (NREM) sleep stage, expressed in percentage [%].
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.
WASO
Wake After Sleep Onset (WASO) measures wakefulness, excluding the wakefulness occurring before sleep onset, and is expressed in minutes or hours.
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.
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.
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.
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.
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].
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.

Full Information

First Posted
January 27, 2022
Last Updated
March 21, 2023
Sponsor
Onera BV
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1. Study Identification

Unique Protocol Identification Number
NCT05310708
Brief Title
Validation Study of a Patch-based PSG System
Official Title
Validation Study of a Patch-based PSG System
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
December 21, 2023 (Anticipated)
Study Completion Date
December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Onera BV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Validation Study of a patch-based PSG system
Arm Type
Experimental
Arm Description
Measuring and recording multiple physiological parameters from a patient which are used by clinicians to make a decision on the diagnosis of sleep.
Intervention Type
Diagnostic Test
Intervention Name(s)
Polysomnography
Intervention Description
Measuring and recording multiple physiological parameters from a patient which are used by clinicians to make a decision on the diagnosis of sleep.
Primary Outcome Measure Information:
Title
EOG left
Description
Electrooculogram (EOG) is measured on the left side. Here, electrical activity of the eye is measured with an electrode and expressed in microvolt[uV].
Time Frame
1 year
Title
EOG right
Description
Electrooculogram (EOG) is measured on the right side. Here, electrical activity of the eye is measured with an electrode and expressed in microvolt[uV].
Time Frame
1 year
Title
EEG left
Description
Electroencephalogram (EEG) is measured on the left side. Here, electrical activity of the brain is measured with an electrode and expressed in microvolt[uV].
Time Frame
1 year
Title
EEG right
Description
Electroencephalogram (EEG) is measured on the right side. Here, electrical activity of the brain is measured with an electrode and expressed in microvolt[uV].
Time Frame
1 year
Title
EMG left
Description
Electromyogram (EMG) is measured on the left side. Here, electrical activity of the muscle is measured with an electrode and expressed in microvolt[uV].
Time Frame
1 year
Title
EMG right
Description
Electromyogram (EMG) is measured on the right side. Here, electrical activity of the muscle is measured with an electrode and expressed in microvolt[uV].
Time Frame
1 year
Title
SpO2
Description
Oxygen Saturation (SpO2) is derived from red and infrared Photoplethysmography (PPG) which is measured on the forehead with a reflective pulse oximetry sensor.
Time Frame
1 year
Title
ECG
Description
Electrocardiogram (ECG) is measured on the chest. Here, electrical activity of the heart is measured with an electrode and expressed in microvolt[mV].
Time Frame
1 year
Title
BioZ Flow
Description
Respiratory Flow (BioZ Flow) is derived from the bioimpedance which is measured on the chest with an electrode (expressed: [a.u.]).
Time Frame
1 year
Title
BioZ Effort
Description
Respiratory Effort (BioZ Effort) is derived from the bioimpedance which is measured on the chest with an electrode (expressed: [a.u.]).
Time Frame
1 year
Title
Activity
Description
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].
Time Frame
1 year
Title
Snoring
Description
Snoring is measured with the microphone imbedded in the sensor on the chest and expressed in Decibel[dB].
Time Frame
1 year
Title
Body Position
Description
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].
Time Frame
1 year
Title
Nasal Cannula Flow
Description
The Nasal Cannula Flow is measured on the belly using a cannula (expressed: [mmH2O]).
Time Frame
1 year
Title
EMG Leg
Description
Electromyogram (EMG) is measured on the lower leg. Here, electrical activity of the muscle is measured with an electrode and expressed in microvolt[mV].
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Total Sleep Time
Description
The total time spend asleep expressed in minutes or hours.
Time Frame
1 year
Title
Time In Bed
Description
The total time spend in bed expressed in minutes or hours.
Time Frame
1 year
Title
SOL
Description
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.
Time Frame
1 year
Title
Wake Time
Description
The total time spend awake expressed in minutes or hours.
Time Frame
1 year
Title
Time in N1
Description
The total time spend in the N1 sleep stage, expressed in minutes or hours.
Time Frame
1 year
Title
Time in N2
Description
The total time spend in the N2 sleep stage, expressed in minutes or hours.
Time Frame
1 year
Title
Time in N3
Description
The total time spend in the N3 sleep stage, expressed in minutes or hours.
Time Frame
1 year
Title
Time in REM
Description
The total time spend in the Rapid Eye Movement (REM) sleep stage, expressed in minutes or hours.
Time Frame
1 year
Title
Time in NREM
Description
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.
Time Frame
1 year
Title
REM
Description
Amount of time spend in the Rapid Eye Movement (REM) sleep stage, expressed in percentage [%].
Time Frame
1 year
Title
NREM
Description
Amount of time spend in the Non Rapid Eye Movement (NREM) sleep stage, expressed in percentage [%].
Time Frame
1 year
Title
REM Onset Latency
Description
The elapsed time between sleep onset and the onset of the first Rapid Eye Movement (REM) sleep period, expressed in minutes or hours.
Time Frame
1 year
Title
WASO
Description
Wake After Sleep Onset (WASO) measures wakefulness, excluding the wakefulness occurring before sleep onset, and is expressed in minutes or hours.
Time Frame
1 year
Title
AI
Description
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.
Time Frame
1 year
Title
AHI
Description
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.
Time Frame
1 year
Title
SpO2
Description
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.
Time Frame
1 year
Title
ODI
Description
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.
Time Frame
1 year
Title
HR
Description
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].
Time Frame
1 year
Title
Set-up Time PSG (not applicable for application in unsupervised home setting)
Description
Comparison of the setup time (fitting and activation) between the Onera STS system and a traditional Polysomnography (PSG) system.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartmut Schneider
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Sleep Clinic
City
Frankfurt
State/Province
Frankfurt Am Main
ZIP/Postal Code
60389
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Validation Study of a Patch-based PSG System

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