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Sleepiz One+ Versus Capnography and Electrocardiography (SPZCAP)

Primary Purpose

COPD, Hypertension, Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Sleepiz One+
Sponsored by
Sleepiz AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Schlaflabor Fluntern

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sleepiz One+ vs. gold standard

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2023
Last Updated
May 4, 2023
Sponsor
Sleepiz AG
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1. Study Identification

Unique Protocol Identification Number
NCT05712226
Brief Title
Sleepiz One+ Versus Capnography and Electrocardiography
Acronym
SPZCAP
Official Title
Single-center Evaluation of Sleepiz One+ in Measuring Respiration Rate and Heart Rate Compared to Gold Standard
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
April 6, 2023 (Actual)
Study Completion Date
April 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sleepiz AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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, the performance of heart rate estimation will be evaluated against ECG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Hypertension, Sleep Apnea, Asthma, Heart Diseases, Respiratory Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Annotators of capnography data were blinded to the values provided by the investigational device
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleepiz One+ vs. gold standard
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sleepiz One+
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed.
Time Frame
60s

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Schlaflabor Fluntern
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8044
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Sleepiz One+ Versus Capnography and Electrocardiography

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