Sleepiz One+ vs. Capnography and Electrocardiography

NCT06569940 | Recruiting

• 1 other identifier: 24-001-CI
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea; Asthma; COPD; Hypertension; Diabetes; Respiratory Disease; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Sleepiz One+ vs. gold standard

OTHER

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+

Interventions

Sleepiz One+ DEVICE

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.

Sleepiz One+ vs. gold standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sleepiz AG: lead

Study Sites (1)

Schlaflabor Fluntern

Zurich, Canton of Zurich, 8044, Switzerland

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Asthma; Pulmonary Disease, Chronic Obstructive; Hypertension; Diabetes Mellitus; Respiration Disorders; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Apnea; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christian Neumann, Dr. med.

  Zentrum für Schlafmedizin "Schlaflabor Fluntern"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Stepien, MSc

CONTACT

+41 44 586 08 88; marta.stepien@sleepiz.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Annotators of capnography data were blinded to the values provided by the investigational device
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 26, 2024
• Study Start: July 18, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)