Sleepiz One+ Versus Capnography and Electrocardiography

Hypertension Clinical Trial

— SPZCAP  

Official title:

Single-center Evaluation of Sleepiz One+ in Measuring Respiration Rate and Heart Rate Compared to Gold Standard

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712226
• Other study ID #: 22-007-CI
• Status: Completed
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: April 6, 2023

Study information

• Verified date: May 2023
• Source: Sleepiz AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

EtCO2, or exhaled carbon dioxide, is a non-invasive and commonly used measure for respiratory rate and function. It can be easily monitored using a device called a capnograph, which consists of a sensor that is placed near the patient's mouth or nose and a monitor that displays the concentration of carbon dioxide in the respiratory gases in real-time.

EtCO2 capnography is generally considered a reliable and accurate method for monitoring respiration and is often used as a gold standard for comparing the performance of other methods for measuring respiration.

Therefore, the primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ and EtCO2 Capnography for measuring respiration rate, in healthy adults and patients suffering from chronic conditions (e.g. hypertension, COPD, asthma, diabetes), at rest in a clinical setting. Additionally, the performance of heart rate estimation will be evaluated against ECG.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 6, 2023
• Est. primary completion date: April 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COPD
• Heart Diseases
• Hypertension
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Sleep Apnea

Intervention

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 35 minutes.

Locations

Country	Name	City	State
Switzerland	Schlaflabor Fluntern	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Sleepiz AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed.		60s