Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation

COPD Clinical Trial

Official title:

Evaluation of Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation in Older People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268538
• Other study ID #: 2016.454
• Status: Completed
• Start date: April 3, 2017
• Est. completion date: August 27, 2018

Study information

• Verified date: May 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: August 27, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Aged 60 years old or more with or without COPD

Exclusion Criteria:

• Current smokers

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
Hong Kong	Medicine	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD	COPD as defined by lung function	6 days