Sleep ApneaNCT04670848
Contactless Detection of Sleep Apnea
A study testing Sleepiz One+ vs. polysomnography in people with Sleep Apnea, run by Sleepiz AG at 1 site in Germany.
Trial summary
In this study the inestigators aim to validate the performance of Sleepiz One+ for sleep apnea detection during routine diagnostic sleep studies. Patients who are prescribed polysomnography study will be asked to participate and undergo a simultaneous sleep recording with radar sensor-based device. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Sleepiz One+ vs. polysomnography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteGermany
- Study dates
- 7 Dec 2020to 21 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18years
- Ability and consent to undergo electrophysiological routine assessment
- Patients suspected to suffer from sleep apnea or any other sleep related disorder
Who cannot join
- Previous enrollment into the current study,
- Enrollment of the investigator, his/her family members and other dependent persons
- Cardiac pacemaker or another implanted electrical device
- Women who are pregnant or breastfeeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsmedizin Essen Ruhrlandklinik
Essen, North Rhine-Westphalia, 45239
About this study
Official title: Validation of a Contactless Sensor for Sleep Apnea Diagnosis Against Polysomnography
In this study the inestigators aim to validate the performance of Sleepiz One+ for sleep apnea detection during routine diagnostic sleep studies. Patients who are prescribed polysomnography study will be asked to participate and undergo a simultaneous sleep recording with radar sensor-based device.
- Conditions
- Sleep Apnea
- Being tested
- Sleepiz One+ vs. polysomnography
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleepiz One+ vs. polysomnographyDevice
Simultaneous sleep recording with polysomnography and Sleepiz One+ device
| Study group | Role | What they receive |
|---|---|---|
| Patients suspected of suffering from sleep apnea | Experimental | Not described Receives: Device: Sleepiz One+ vs. polysomnography |
| Healthy volunteers | Experimental | Not described Receives: Device: Sleepiz One+ vs. polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary classification of subjects based on their sleep apnea severity (AHI ≥= 15) made by Sleepiz One+, compared to PSG data manually scored by sleep technicians
Measured: 1 Night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start7 Dec 2020
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sleepiz AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Schöbel, Prof. Dr. med., Principal investigator, Universitätsmedizin Essen Ruhrlandklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670848
- Sponsor's protocol ID
- PSG-Apnea-Essen
- Status last verified
- Jan 2022
- First submitted
- 9 Dec 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gross-Isselmann JA, Eggert T, Wildenauer A, Dietz-Terjung S, Grosse Sundrup M, Schoebel C. Validation of the Sleepiz One + as a radar-based sensor for contactless diagnosis of sleep apnea. Sleep Breath. 2024 Aug;28(4):1691-1699. doi: 10.1007/s11325-024-03057-6. Epub 2024 May 14.
PubMed 38744804
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Contactless Sensor for Sleep Apnea Diagnosis Against Polysomnography
- ClinicalTrials.gov ID
- NCT04670848
- Acronym / sponsor ID
- PSG-Apnea-Essen
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Sleepiz AGIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the inestigators aim to validate the performance of Sleepiz One+ for sleep apnea detection during routine diagnostic sleep studies. Patients who are prescribed polysomnography study will be asked to participate and undergo a simultaneous sleep recording with radar sensor-based device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of suffering from sleep apnea | Experimental | Device: Sleepiz One+ vs. polysomnography |
| Healthy volunteers | Experimental | Device: Sleepiz One+ vs. polysomnography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18years
- Ability and consent to undergo electrophysiological routine assessment
- Patients suspected to suffer from sleep apnea or any other sleep related disorder
Key exclusion criteria (5 listed)
- Previous enrollment into the current study,
- Enrollment of the investigator, his/her family members and other dependent persons
- Cardiac pacemaker or another implanted electrical device
- Women who are pregnant or breastfeeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleepiz One+ vs. polysomnographySimultaneous sleep recording with polysomnography and Sleepiz One+ device | Device | Healthy volunteers, Patients suspected of suffering from sleep apnea |
Primary outcome
Binary classification of subjects based on their sleep apnea severity (AHI ≥= 15) made by Sleepiz One+, compared to PSG data manually scored by sleep technicians
Time frame: 1 Night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Derived from this study: PubMed 38744804Gross-Isselmann JA, Eggert T, Wildenauer A, Dietz-Terjung S, Grosse Sundrup M, Schoebel C. Validation of the Sleepiz One + as a radar-based sensor for contactless diagnosis of sleep apnea. Sleep Breath. 2024 Aug;28(4):1691-1699. doi: 10.1007/s11325-024-03057-6. Epub 2024 May 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Schöbel, Prof. Dr. med. principal investigator
Universitätsmedizin Essen Ruhrlandklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleepiz One+ vs. polysomnography in people with Sleep Apnea, run by Sleepiz AG at 1 site 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 5 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: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Binary classification of subjects based on their sleep apnea severity (AHI ≥= 15) made by Sleepiz One+, compared to PSG data manually scored by sleep technicians (time frame: 1 Night). 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 NCT04670848, 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 25 Jan 2022.