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Sleep DisorderNCT05310708

Validation Study of a Patch-based PSG System

A study testing Polysomnography in people with Sleep Disorder, run by Onera BV at 7 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sleep Disorder
What is being tested?
Polysomnography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
7 sitesGermany
Study dates
21 Jan 2022to 21 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Schlaf- u. Beatmungszentrum Ulm/Blaubeuren

    Blaubeuren Abbey, 89143

  • Ruhrlandklinik, Zentrum für Schlaf- und Telemedizin

    Essen, 45239

  • Evang. Kliniken Essen-Mitte

    Essen, 45276

  • American Sleep Clinic

    Frankfurt, Frankfurt Am Main, 60389

  • VAMED Klinik Hagen-Ambrock

    Hagen, 58091

  • Universitätsklinikum Giessen und Marburg

    Marburg, 35043

  • Krankenhaus Bethanien

    Solingen, 42699

Other trials in Germany

About this study

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
Being tested
Polysomnography
Medical subject headings
Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PolysomnographyDiagnostic test

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

Study groups in NCT05310708
Study groupRoleWhat they receive
Validation Study of a patch-based PSG systemExperimentalMeasuring and recording multiple physiological parameters from a patient which are used by clinicians to make a decision on the diagnosis of sleep.
Receives: Diagnostic Test: Polysomnography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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].

    Measured: 1 year

  2. 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].

    Measured: 1 year

  3. 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].

    Measured: 1 year

  4. 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].

    Measured: 1 year

  5. 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].

    Measured: 1 year

  6. 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].

    Measured: 1 year

  7. SpO2

    Oxygen Saturation (SpO2) is derived from red and infrared Photoplethysmography (PPG) which is measured on the forehead with a reflective pulse oximetry sensor.

    Measured: 1 year

  8. ECG

    Electrocardiogram (ECG) is measured on the chest. Here, electrical activity of the heart is measured with an electrode and expressed in microvolt[mV].

    Measured: 1 year

  9. BioZ Flow

    Respiratory Flow (BioZ Flow) is derived from the bioimpedance which is measured on the chest with an electrode (expressed: [a.u.]).

    Measured: 1 year

  10. BioZ Effort

    Respiratory Effort (BioZ Effort) is derived from the bioimpedance which is measured on the chest with an electrode (expressed: [a.u.]).

    Measured: 1 year

  11. 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].

    Measured: 1 year

  12. Snoring

    Snoring is measured with the microphone imbedded in the sensor on the chest and expressed in Decibel[dB].

    Measured: 1 year

  13. 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].

    Measured: 1 year

  14. Nasal Cannula Flow

    The Nasal Cannula Flow is measured on the belly using a cannula (expressed: [mmH2O]).

    Measured: 1 year

  15. 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].

    Measured: 1 year

Secondary outcomes (19)

  1. Total Sleep Time

    The total time spend asleep expressed in minutes or hours.

    Measured: 1 year

  2. Time In Bed

    The total time spend in bed expressed in minutes or hours.

    Measured: 1 year

  3. 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.

    Measured: 1 year

  4. Wake Time

    The total time spend awake expressed in minutes or hours.

    Measured: 1 year

  5. Time in N1

    The total time spend in the N1 sleep stage, expressed in minutes or hours.

    Measured: 1 year

  6. Time in N2

    The total time spend in the N2 sleep stage, expressed in minutes or hours.

    Measured: 1 year

  7. Time in N3

    The total time spend in the N3 sleep stage, expressed in minutes or hours.

    Measured: 1 year

  8. Time in REM

    The total time spend in the Rapid Eye Movement (REM) sleep stage, expressed in minutes or hours.

    Measured: 1 year

  9. 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.

    Measured: 1 year

  10. REM

    Amount of time spend in the Rapid Eye Movement (REM) sleep stage, expressed in percentage [%].

    Measured: 1 year

  11. NREM

    Amount of time spend in the Non Rapid Eye Movement (NREM) sleep stage, expressed in percentage [%].

    Measured: 1 year

  12. 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.

    Measured: 1 year

  13. WASO

    Wake After Sleep Onset (WASO) measures wakefulness, excluding the wakefulness occurring before sleep onset, and is expressed in minutes or hours.

    Measured: 1 year

  14. 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.

    Measured: 1 year

  15. 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.

    Measured: 1 year

  16. 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.

    Measured: 1 year

  17. 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.

    Measured: 1 year

  18. 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].

    Measured: 1 year

  19. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start21 Jan 2022
  3. Primary completion21 Jun 2024 (estimated)
  4. Study completion21 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05310708
Sponsor's protocol ID
CIP_Protocol_Onera_R01
Status last verified
Apr 2024
First submitted
27 Jan 2022
Last updated
8 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39773950

Questions about this trial

What is this clinical trial studying?

A study testing Polysomnography in people with Sleep Disorder, run by Onera BV at 7 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EOG left (time frame: 1 year). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05310708, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.

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