Sleep ApneaNCT06569940
Sleepiz One+ vs. Capnography and Electrocardiography
A study testing Sleepiz One+ in people with Sleep Apnea and Asthma, run by Sleepiz AG at 1 site in Switzerland.
Trial summary
Respiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors. Effective management of chronic diseases relies on detecting pathological changes early, with RR being among the most sensitive predictors of patient… 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, Asthma, COPD
- What is being tested?
- Sleepiz One+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jul 2024to 30 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- Age >=18years
- Informed Consent as documented by signature
- One (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.)
- Healthy volunteers
- Age >=18years
- Informed Consent as documented by signature
- No diagnosed chronic medical condition
Who cannot join
- Patients
- Previous enrolment into the current study,
- 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
- Healthy volunteers:
Show all 11Show fewer
- Previous enrolment into the current study,
- 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
- Presence of diagnosed chronic medical condition
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Schlaflabor Fluntern
Zurich, Canton of Zurich, 8044
Christian Neumann, Dr. med,
About this study
Official title: Single-center Evaluation of Sleepiz One+ Algorithm in Estimating Respiration Rate and Heart Rate Compared to Gold Standard
Respiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors. Effective management of chronic diseases relies on detecting pathological changes early, with RR being among the most sensitive predictors of patient deterioration. Therefore, vigilant monitoring of RR and HR is vital for improving patient outcomes.
The primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ algorithms and end-tidal carbon dioxide measurement (EtCO2) Capnography for measuring respiration rate and electrocardiography (ECG) for measuring heart rate, in healthy adults and patients suffering from chronic conditions (e.g., hypertension, Chronic Obstructive Pulmonary Disease (COPD), asthma, diabetes), at rest in a clinical setting when the data is acquired with the new hardware version. Additionally, the investigators will evaluate the performance of RR estimation against the thoracic effort belt and the HR against the pulse oximetry.
- Conditions
- Sleep Apnea, Asthma, COPD, Hypertension, Diabetes, Respiratory Disease
- Being tested
- Sleepiz One+
- Medical subject headings
- Sleep Apnea Syndromes, Asthma, Pulmonary Disease, Chronic Obstructive, Hypertension, Diabetes Mellitus, Respiration Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleepiz One+Device
In this study Sleepiz One+ will measure heart rate and respiration rate of a participant sitting or lying in different positions (right and left side, back, abdomen) on a bed. The recording will take around 42 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Sleepiz One+ vs. gold standard | Other | Each enrolled participant will undergo a simultaneous recording with the Sleepiz One+, Capnography device and cardiorespiratory polygraphy to measure respiration rate at and heart rate at rest, while sitting and lying down on a bed. Receives: Device: Sleepiz One+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instantaneous respiration rate measurement accuracy per 60s epoch
Instantaneous respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed
Measured: During 60 seconds
Instantaneous heart rate measurement accuracy per 60s epoch
Instantaneous heart rate measurement accuracy per 60s epoch against ECG R-R interval, recorded on subjects lying down and resting on a bed
Measured: During 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start18 Jul 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sleepiz AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Neumann, Dr. med., Principal investigator, Zentrum für Schlafmedizin "Schlaflabor Fluntern"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569940
- Sponsor's protocol ID
- 24-001-CI
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Evaluation of Sleepiz One+ Algorithm in Estimating Respiration Rate and Heart Rate Compared to Gold Standard
- ClinicalTrials.gov ID
- NCT06569940
- Acronym / sponsor ID
- 24-001-CI
- Conditions
- Sleep Apnea, Asthma, COPD, Hypertension, Diabetes, Respiratory Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sleepiz AGIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 26 Aug 2024 (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.
Respiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors. Effective management of chronic diseases relies on detecting pathological changes early, with RR being among the most sensitive predictors of patient deterioration. Therefore, vigilant monitoring of RR and HR is vital for improving patient outcomes.
The primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ algorithms and end-tidal carbon dioxide measurement (EtCO2) Capnography for measuring respiration rate and electrocardiography (ECG) for measuring heart rate, in healthy adults and patients suffering from chronic conditions (e.g., hypertension, Chronic Obstructive Pulmonary Disease (COPD), asthma, diabetes), at rest in a clinical setting when the data is acquired with the new hardware version. Additionally, the investigators will evaluate the performance of RR estimation against the thoracic effort belt and the HR against the pulse oximetry.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleepiz One+ vs. gold standard | Other | Device: Sleepiz One+Each enrolled participant will undergo a simultaneous recording with the Sleepiz One+, Capnography device and cardiorespiratory polygraphy to measure respiration rate at and heart rate at rest, while sitting and lying down on a bed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >=18years
- Informed Consent as documented by signature
- One (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.)
- Healthy volunteers
- Age >=18years
Key exclusion criteria (11 listed)
- Patients
- Previous enrolment into the current study,
- 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+In this study Sleepiz One+ will measure heart rate and respiration rate of a participant sitting or lying in different positions (right and left side, back, abdomen) on a bed. The recording will take around 42 minutes. | Device | Sleepiz One+ vs. gold standard |
Primary outcome
Instantaneous respiration rate measurement accuracy per 60s epoch
Time frame: During 60 seconds
Instantaneous respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed
Instantaneous heart rate measurement accuracy per 60s epoch
Time frame: During 60 seconds
Instantaneous heart rate measurement accuracy per 60s epoch against ECG R-R interval, recorded on subjects lying down and resting on a bed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- 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.
Christian Neumann, Dr. med. principal investigator
Zentrum für Schlafmedizin "Schlaflabor Fluntern"
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+ in people with Sleep Apnea and Asthma, run by Sleepiz AG at 1 site in Switzerland.
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 8 inclusion and 11 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 26 Aug 2024. 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 Switzerland. 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?
Contact Marta Stepien, MSc (+41 44 586 08 88, marta.stepien@sleepiz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instantaneous respiration rate measurement accuracy per 60s epoch (time frame: During 60 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2024.