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NCT Number: NCT06569940

Sleepiz One+ vs. Capnography and Electrocardiography

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.

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Key information

Conditions

Sleep Apnea Apnea Asthma Bronchial Diseases COPD Cardiovascular Diseases Chronic Disease Diabetes Diabetes Mellitus Disease Attributes Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Hypersensitivity Hypersensitivity, Immediate Hypertension Immune System Diseases Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Disease Respiratory Hypersensitivity Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schlaflabor Fluntern

Zurich, Canton of Zurich, 8044, Switzerland

Location status: Recruiting

Location contact

Christian Neumann, Dr. med,

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Instantaneous respiration rate measurement accuracy per 60s epoch

    Time frame: During 60 seconds

    Instantaneous respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed

  2. Instantaneous heart rate measurement accuracy per 60s epoch

    Time frame: During 60 seconds

    Instantaneous heart rate measurement accuracy per 60s epoch against ECG R-R interval, recorded on subjects lying down and resting on a bed

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Stepien, MSc

CONTACT

[email protected]

+41 44 586 08 88

Sponsors and collaborators

Lead sponsor

Sleepiz AG

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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