Photophlethysmography Evaluation of Pulse Waveform

NCT ID: NCT03725189

Last Updated: 2020-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-12-01

Brief Summary

Aim 1. To explore a novel, non-invasive PPG technology for purposes of monitoring heart rate variability and pulse waveform by harmonic resonance analysis.

Aim 2. To analyze collected data to determine whether it provides useful information about other measures of underlying health.

Detailed Description

The proposed study will first investigate whether a novel PPG device will be able to measure the harmonic-analysis indexes of the blood pressure waveform (BPWs) to provide information about arterial pulse transmission (by monitoring arterial pulse waveform, Cn) and cardiovascular regulatory activities (by monitoring coefficients of variation, CVn).

Secondarily, data on Cn and CVn could be useful for detecting the arterial elastic properties induced by external stimulation such as exercise, cold stimulation, mental stress, acupuncture, medications such as antihypertensive drugs, or pathological factors such as metabolic syndrome, and breast cancer. The collected data may thus provide information about underlying health.

Photoplethysmography (PPG) is a non-invasive optical technique for evaluating the pulse and hemodynamic changes in frequency. The device obtains a volumetric measurement of an organ via optical illumination (e.g LED). PPG has been used to determine the PaO2, heart rate, and blood pressure (systolic blood pressure, SBP and diastolic blood pressure, DBP) at fingertip and harmonic proportion at fingertip or from the radial artery waveform at the wrist.

However, to the investigator's knowledge, this is the first preliminary study to determine the effects of physical activity on harmonic proportion evaluating by PPG at fingertip. Ultimately, this data may help to develop a non-invasive, external device that could rapidly detect information about cardiovascular and underlying health.

Conditions

Healthy

Keywords

Photophlethysmograph; device; pulse waveform

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

PPG Group

Testing of PPG device in healthy adult population doing cardiovascular exercise

Group Type: EXPERIMENTAL

PPG during exercise

Intervention Type: DEVICE

PPG use for pulse waveform evaluation of healthy exercise group

Interventions

PPG during exercise

PPG use for pulse waveform evaluation of healthy exercise group

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Ability to understand consent (no proxy consent) in English or Chinese.

2. Self-Reported ability to undertake a 20 minute cycling activity at 60-70% exercise intensity.

3. Ability and willingness to abstain from use of medications for three days preceding cycling activity, smoking/intense exercise/alcohol for 12 hours preceding cycling activity, and caffeine intake for 4 hours preceding cycling.

Exclusion Criteria

1. Inability to finish a 20 min cycling activity in 60-70% exercise intensity.

2. Adverse reaction to adhesive tape.

3. Raynaud's phenomenon

4. Angina or recent myocardial infarction (previous 6 months)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan Normal University

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Kakit P. Hui, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ka-Kit Hui, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

National Taiwan Normal University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

00000

Identifier Type: -

Identifier Source: org_study_id