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SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter During Hypoxia (HYPOWATCH)

Primary Purpose

Hypoxia, Pulse Oximetry

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Breathing mixtures of O2 and N2 and monitoring SpO2 on finger and left wrist
Sponsored by
Czech Technical University in Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoxia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure, blood oxygen saturation and medical history Exclusion Criteria: pregnancy severe cardiovascular conditions severe asthma or other severe respiratory conditions injury to the upper limbs or hands that could affect the peripheral perfusion diabetes hypotension or hypertension

Sites / Locations

  • Czech Technical University in Prague

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypoxia

Arm Description

Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the whole experiment, non-invasive SpO2 measurements will be performed on the middle finger and on the wrist of left hand.

Outcomes

Primary Outcome Measures

Is there any difference in measured SpO2 between finger and wrist during induced hypoxia?
The agreement of SpO2 measurements of both monitoring devices will be evaluated.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2022
Last Updated
March 16, 2023
Sponsor
Czech Technical University in Prague
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1. Study Identification

Unique Protocol Identification Number
NCT05657288
Brief Title
SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter During Hypoxia
Acronym
HYPOWATCH
Official Title
SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague

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
The aim of the project is to experimentally compare SpO2 measured on a wrist by commercial Smartwach and on a finger measured by a medical-grade pulse oximeter in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).
Detailed Description
The newest models of smartwatches measure peripheral blood oxygen saturation (SpO2) and the technology is rapidly improving. The results of individual studies on the accuracy of SpO2 measurement using smartwatches from different brands are still inconclusive. The study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. The agreement of the measurements of both devices will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Pulse Oximetry

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional prospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypoxia
Arm Type
Experimental
Arm Description
Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the whole experiment, non-invasive SpO2 measurements will be performed on the middle finger and on the wrist of left hand.
Intervention Type
Other
Intervention Name(s)
Breathing mixtures of O2 and N2 and monitoring SpO2 on finger and left wrist
Intervention Description
Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the whole experiment, non-invasive SpO2 measurements will be performed on the middle finger and on the wrist of left hand.
Primary Outcome Measure Information:
Title
Is there any difference in measured SpO2 between finger and wrist during induced hypoxia?
Description
The agreement of SpO2 measurements of both monitoring devices will be evaluated.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure, blood oxygen saturation and medical history Exclusion Criteria: pregnancy severe cardiovascular conditions severe asthma or other severe respiratory conditions injury to the upper limbs or hands that could affect the peripheral perfusion diabetes hypotension or hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Walzel, MSc.
Organizational Affiliation
Czech Technical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Czech Technical University in Prague
City
Kladno
ZIP/Postal Code
27201
Country
Czechia

12. IPD Sharing Statement

Citations:
PubMed Identifier
36249475
Citation
Rafl J, Bachman TE, Rafl-Huttova V, Walzel S, Rozanek M. Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study. Digit Health. 2022 Oct 11;8:20552076221132127. doi: 10.1177/20552076221132127. eCollection 2022 Jan-Dec.
Results Reference
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SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter During Hypoxia

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