COPDNCT03268538
Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation
An observational study of COPD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Introduction: Chronic obstructive airway disease (COPD) is common condition in old age and the perception of hypoxia is often impaired in some COPD patients. Therefor it is need to monitor oxygen saturation in older people with COPD. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 277 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Apr 2017to 27 Aug 2018
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 COPD and 200 healthy older people
Who may be able to join
- Aged 60 years old or more with or without COPD
Who cannot join
- Current smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation in Older People
Introduction: Chronic obstructive airway disease (COPD) is common condition in old age and the perception of hypoxia is often impaired in some COPD patients. Therefor it is need to monitor oxygen saturation in older people with COPD. A finger wearable device has been developed to measure oxygen saturation and heart rate variability. The investigators therefore will perform a cross sectional study to evaluate the clinical application of this finger wearable device in the detection and management of COPD in older people.
Subject and method: 100 COPD subjects and 200 community dwelling older people without diagnosis of COPD will be recruited. Physical functioning and lung function test will be performed. Subjects will wear a finger wearable device to monitor heart rate variability and oxygen saturation and wear another wrist wearable device (Actigraph) to monitor physical activity and sleep for 6 days at the same time.
Statistical analysis: Statistical analysis will be made to examine the potential association between oxygen saturation and physical activity and sleep, and the association between heart rate variability and physical activity and sleep.
- Conditions
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD
COPD as defined by lung function
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start3 Apr 2017
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Kwok, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268538
- Sponsor's protocol ID
- 2016.454
- Status last verified
- May 2019
- First submitted
- 29 Aug 2017
- Last updated
- 6 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation in Older People
- ClinicalTrials.gov ID
- NCT03268538
- Acronym / sponsor ID
- 2016.454
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 31 Aug 2017 (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.
Introduction: Chronic obstructive airway disease (COPD) is common condition in old age and the perception of hypoxia is often impaired in some COPD patients. Therefor it is need to monitor oxygen saturation in older people with COPD. A finger wearable device has been developed to measure oxygen saturation and heart rate variability. The investigators therefore will perform a cross sectional study to evaluate the clinical application of this finger wearable device in the detection and management of COPD in older people.
Subject and method: 100 COPD subjects and 200 community dwelling older people without diagnosis of COPD will be recruited. Physical functioning and lung function test will be performed. Subjects will wear a finger wearable device to monitor heart rate variability and oxygen saturation and wear another wrist wearable device (Actigraph) to monitor physical activity and sleep for 6 days at the same time.
Statistical analysis: Statistical analysis will be made to examine the potential association between oxygen saturation and physical activity and sleep, and the association between heart rate variability and physical activity and sleep.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 COPD and 200 healthy older people
Key inclusion criteria (1 listed)
- Aged 60 years old or more with or without COPD
Key exclusion criteria (1 listed)
- Current smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COPD
Time frame: 6 days
COPD as defined by lung function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COPD, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 May 2019. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2019.