SPZCAP: Sleepiz One+ Versus Capnography and Electrocardiography

Sponsor

Sleepiz AG (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05712226

Collaborator

(none)

Enrollment

Arm

1.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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, we will evaluate the performance of heart rate estimation against ECG.

Condition or Disease	Intervention/Treatment	Phase
COPD Hypertension Sleep Apnea Asthma Heart Diseases Respiratory Disease	Device: Sleepiz One+	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Feb 13, 2023

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Sleepiz One+ vs. gold standard Each enrolled participant will undergo a simultaneous recording with the Sleepiz One+, Capnography device and cardiorespiratory polygraphy with reduced number of channels (ECG and REB only) to measure respiration rate at and heart rate at rest, while sitting and lying down on a bed.	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.

Arm

Intervention/Treatment

Other: Sleepiz One+ vs. gold standard

Each enrolled participant will undergo a simultaneous recording with the Sleepiz One+, Capnography device and cardiorespiratory polygraphy with reduced number of channels (ECG and REB only) to measure respiration rate at and heart rate at rest, while sitting and lying down on a bed.

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.

Outcome Measures

Primary Outcome Measures

Respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed. [60s]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sleepiz AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sleepiz AG

ClinicalTrials.gov Identifier:

NCT05712226

Other Study ID Numbers:

22-007-CI

First Posted:

Feb 3, 2023

Last Update Posted:

Feb 3, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiration Disorders

Respiratory Tract Diseases

Heart Diseases

Study Results

No Results Posted as of Feb 3, 2023