Sleepiz One+ vs. Capnography and Electrocardiography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sleepiz One+.
- Who it may be relevant to
- Registry conditions: Sleep Apnea, Asthma, COPD, Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Single-center Evaluation of Sleepiz One+ Algorithm in Estimating Respiration Rate and Heart Rate Compared to Gold Standard
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Instantaneous respiration rate measurement accuracy per 60s epoch [Time frame: During 60 seconds]
- Instantaneous heart rate measurement accuracy per 60s epoch [Time frame: During 60 seconds]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Switzerland · 1 center
- Schlaflabor Fluntern — Zurich
Identifiers
NCT: NCT06569940 · 24-001-CI