Sleepiz One+ vs. Capnography and Electrocardiography

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Hypertension; Diabetes; Asthma; Sleep Apnea; COPD; Respiratory Disease
• Intervention / Treatment: Device: Sleepiz One+

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Stepien, MSc; Phone Number: +41 44 586 08 88; Email: marta.stepien@sleepiz.com

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8044
      • Recruiting
      • Schlaflabor Fluntern
      • Contact: Christian Neumann, Dr. med,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 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 42 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	During 60 seconds

Collaborators and Investigators

• Sponsor: Sleepiz AG
• Investigators: Principal Investigator: Christian Neumann, Dr. med., Zentrum für Schlafmedizin "Schlaflabor Fluntern"

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 24-001-CI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No