Oxygen SaturationDSHWDNCT04429906
Diagnostic Study of Huami Smart Wearable Device
An observational study of Oxygen Saturation, run by Peking University First Hospital at 1 site in China.
Trial summary
This is a cross-sectional diagnostic study. In this study, wrist oxygen saturation (SwO2) will be measured by Huami smart wearable device, SpO2 of pulse oxygen saturation monitor with medical device registration certificate and SaO2 of arterial blood gas analysis will be used as reference values. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Oxygen Saturation
- What is being tested?
- Huami smart wearable device
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2020to 30 Jun 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients in the Department of Respiratory and Critical Care at Peking University First Hospital
Who may be able to join
- Inpatients in the Department of Respiratory and Critical Care at Peking University First Hospital
- Oxygen intake or no oxygen intake when enrolled: 80%≤SaO2/SpO2≤100%
- Age between 18 and 85 years, either gender
- COHb<3%, MetHb<2%;
- Sign an informed consent or sign an informed consent by a legally authorized representative;
- Be willing and able to follow the research program.
Who cannot join
- current smokers or those exposed to high levels of carbon monoxide.
- critically ill patients who are in a state of shock, resulting in peripheral circulation disorders.
- Patients with hypothermia below 35°C.
- Patients with bilateral wrist and hand oedema, soft tissue damage to the wrist, skin incomplete and unable to wear a watch/ bracelet.
- Vascular blood supply abnormalities of both upper limbs (occlusion, thrombosis, post-trauma, etc.), which affects the test results
- Patients with bilateral upper extremity pigmentation affecting the test results;
- Patients with limb mobility impairment due to severe cerebrovascular disease sequelae.
- Patients with severe mental system disease that makes it impossible to cooperate with the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Guangfa Wang, MD., 13810644029, wangguangfa@hotmail.com
Jiping Liao, PhD., 13521714181, colorfulwing01@163.com
About this study
Official title: Evaluation of Accuracy of Blood Oxygen Saturation Detection Function of Huami Smart Wearable Device
This is a cross-sectional diagnostic study. In this study, wrist oxygen saturation (SwO2) will be measured by Huami smart wearable device, SpO2 of pulse oxygen saturation monitor with medical device registration certificate and SaO2 of arterial blood gas analysis will be used as reference values. A total of 180 group data will be measured in 30~50 patients with SaO2/ SpO2 between 80%∽100%. The investigators aim to evaluate the accuracy of blood oxygen saturation detection function of huami smart wearable device.
Read the detailed description
This is a cross-sectional diagnostic study. 30~50 inpatient aged 18～85y with SaO2/ SpO2 between 80%∽100% will be recruited from the Department of Respiratory and Critical Care of Peking University First Hospital. 180 group data ( 37 of SaO2/ SpO2 between 80%∽90%, 143 of SaO2/ SpO2 between 90%∽100%) will be measured, with an average of 4-6 groups per patient. Some clinical information such as demographic data, laboratory tests, comorbidity, smoking habit and will be collected. Patients have their pulse oximetry measured multiple times using a pulse oximeter/tabletop electrocardiograph with a medical device registration certificate, and arterial blood gas analysis will be performed if required. While monitoring the pulse oximetry, a Huami smart wearable device is worn on the ipsilateral wrist to determine blood oxygen saturation. Primary outcome is the wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference..
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2020-114). Any protocol modifications will be submitted for the IRB review and approval.
- Conditions
- Oxygen Saturation
- Being tested
- Huami smart wearable device
- Keywords
- Oxygen saturation Smart wearable device Accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huami smart wearable deviceDevice
Wear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the "Oxygen Saturation" measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.
| Study group | Role | What they receive |
|---|---|---|
| test group | Wear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the "Oxygen Saturation" measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group. Receives: Device: Huami smart wearable device | |
| control group A | Pulse oximetry monitor/desktop ECG monitor with a medical device registration certificate was selected as reference device A. The mean value of qualified pulse oximetry measured by pulse oximetry monitor/desktop ECG monitor within 2 minutes of each successive measurement of the Huami Smart Wearable Device was used as control group A measurement. | |
| control group B | A carbon monoxide blood gas analyzer (CO-oximeter) was selected as reference device B. Arterial blood was sampled and arterial oxygen saturation (SaO2) was obtained from the blood gas analyzer as a control group B measurement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wearable device oximetry accuracy Arms
Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.
Pulse oximetry monitor/desktop ECG monitor with a medical device registration certificate was selected as reference device A. The mean value of qualified pulse oximetry measured by pulse oximetry monitor/desktop ECG monitor was used as control group A measurement.
Wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference.
Measured: 30mins
Secondary outcomes (5)
Wearable device blood oxygen saturation accuracy Arms
Record the pulse oximetry and pulse rate values measured by the Huami Smart Wearable Pulse Oximetry Device. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.A carbon monoxide blood gas analyzer (CO-oximeter) was selected as reference device B. Arterial blood was sampled and arterial oxygen saturation (SaO2) was obtained from the blood gas analyzer as a control group B measurement.Wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.
Measured: 30mins
Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 90%-100%.
When SpO2/SaO2 is at 90%-100%,wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference;wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.
Measured: 30mins
Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 80%-89%.
when SpO2/SaO2 is at 80%-89%,wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference;wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.
Measured: 30mins
Correlation analysis of parameters that have an impact on the accuracy of blood oxygen saturation of wearable devices.
When the test result is negative, evaluate the parameters that have an impact on the accuracy of blood oxygen saturation of wearable devices.
Measured: 30mins
The variability of blood oxygen saturation of wearable devices tested three times.
Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. Evaluate the variability of blood oxygen saturation of wearable devices tested three times.
Measured: 30mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start29 May 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxygen SaturationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Huami Information Technology Co., Ltd.
- Responsible party
- Principal investigator, Guangfa Wang, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429906
- Sponsor's protocol ID
- 2020114-0604
- Acronym
- DSHWD
- Status last verified
- Jun 2020
- First submitted
- 4 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olsen M, Zeitzer JM, Richardson RN, Davidenko P, Jennum PJ, Sorensen HBD, Mignot E. A Flexible Deep Learning Architecture for Temporal Sleep Stage Classification Using Accelerometry and Photoplethysmography. IEEE Trans Biomed Eng. 2023 Jan;70(1):228-237. doi: 10.1109/TBME.2022.3187945. Epub 2022 Dec 26.
PubMed 35786544
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy of Blood Oxygen Saturation Detection Function of Huami Smart Wearable Device
- ClinicalTrials.gov ID
- NCT04429906
- Acronym / sponsor ID
- DSHWD / 2020114-0604
- Conditions
- Oxygen Saturation
- Keywords
- Oxygen saturation Smart wearable device Accuracy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Anhui Huami Information Technology Co., Ltd.
- Study start
- 29 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cross-sectional diagnostic study. In this study, wrist oxygen saturation (SwO2) will be measured by Huami smart wearable device, SpO2 of pulse oxygen saturation monitor with medical device registration certificate and SaO2 of arterial blood gas analysis will be used as reference values. A total of 180 group data will be measured in 30~50 patients with SaO2/ SpO2 between 80%∽100%. The investigators aim to evaluate the accuracy of blood oxygen saturation detection function of huami smart wearable device.
Detailed description
This is a cross-sectional diagnostic study. 30~50 inpatient aged 18～85y with SaO2/ SpO2 between 80%∽100% will be recruited from the Department of Respiratory and Critical Care of Peking University First Hospital. 180 group data ( 37 of SaO2/ SpO2 between 80%∽90%, 143 of SaO2/ SpO2 between 90%∽100%) will be measured, with an average of 4-6 groups per patient. Some clinical information such as demographic data, laboratory tests, comorbidity, smoking habit and will be collected. Patients have their pulse oximetry measured multiple times using a pulse oximeter/tabletop electrocardiograph with a medical device registration certificate, and arterial blood gas analysis will be performed if required. While monitoring the pulse oximetry, a Huami smart wearable device is worn on the ipsilateral wrist to determine blood oxygen saturation. Primary outcome is the wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference..
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2020-114). Any protocol modifications will be submitted for the IRB review and approval.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| test group | – | Device: Huami smart wearable deviceWear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the "Oxygen Saturation" measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group. |
| control group A | – | –Pulse oximetry monitor/desktop ECG monitor with a medical device registration certificate was selected as reference device A. The mean value of qualified pulse oximetry measured by pulse oximetry monitor/desktop ECG monitor within 2 minutes of each successive measurement of the Huami Smart Wearable Device was used as control group A measurement. |
| control group B | – | –A carbon monoxide blood gas analyzer (CO-oximeter) was selected as reference device B. Arterial blood was sampled and arterial oxygen saturation (SaO2) was obtained from the blood gas analyzer as a control group B measurement. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients in the Department of Respiratory and Critical Care at Peking University First Hospital
Key inclusion criteria (6 listed)
- Inpatients in the Department of Respiratory and Critical Care at Peking University First Hospital
- Oxygen intake or no oxygen intake when enrolled: 80%≤SaO2/SpO2≤100%
- Age between 18 and 85 years, either gender
- COHb<3%, MetHb<2%;
- Sign an informed consent or sign an informed consent by a legally authorized representative;
Key exclusion criteria (8 listed)
- current smokers or those exposed to high levels of carbon monoxide.
- critically ill patients who are in a state of shock, resulting in peripheral circulation disorders.
- Patients with hypothermia below 35°C.
- Patients with bilateral wrist and hand oedema, soft tissue damage to the wrist, skin incomplete and unable to wear a watch/ bracelet.
- Vascular blood supply abnormalities of both upper limbs (occlusion, thrombosis, post-trauma, etc.), which affects the test results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huami smart wearable deviceWear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the "Oxygen Saturation" measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group. | Device | test group |
Primary outcome
Wearable device oximetry accuracy Arms
Time frame: 30mins
Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group. Pulse oximetry monitor/desktop ECG monitor with a medical device registration certificate was selected as reference device A. The mean value of qualified pulse oximetry measured by pulse oximetry monitor/desktop ECG monitor was used as control group A measurement. Wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference.
5 secondary outcomes
Wearable device blood oxygen saturation accuracy Arms
Time frame: 30mins
Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 90%-100%.
Time frame: 30mins
Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 80%-89%.
Time frame: 30mins
Correlation analysis of parameters that have an impact on the accuracy of blood oxygen saturation of wearable devices.
Time frame: 30mins
The variability of blood oxygen saturation of wearable devices tested three times.
Time frame: 30mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Derived from this study: PubMed 35786544Olsen M, Zeitzer JM, Richardson RN, Davidenko P, Jennum PJ, Sorensen HBD, Mignot E. A Flexible Deep Learning Architecture for Temporal Sleep Stage Classification Using Accelerometry and Photoplethysmography. IEEE Trans Biomed Eng. 2023 Jan;70(1):228-237. doi: 10.1109/TBME.2022.3187945. Epub 2022 Dec 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Saturation, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wearable device oximetry accuracy Arms (time frame: 30mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04429906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020; AzTrials last refreshed its copy on 31 Oct 2026.