NCT03725189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2019

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 10, 2020

Status Verified

December 1, 2020

Enrollment Period

1.6 years

First QC Date

October 11, 2018

Last Update Submit

December 8, 2020

Conditions

Healthy

Keywords

Photophlethysmographdevicepulse waveform

Outcome Measures

Primary Outcomes (1)

  • Harmonic measures (C1-C10) by PPG device

    C1-C10 by PPG device

    70 minutes on Day 1 for resting, exercise, and cool down measurements

Secondary Outcomes (9)

  • Demographic Information

    Day 1

  • General health

    Day 1

  • Weight

    Day 1

  • Height

    Day 1

  • Body mass index (BMI)

    Day 1

  • +4 more secondary outcomes

Study Arms (1)

PPG Group

EXPERIMENTAL

Testing of PPG device in healthy adult population doing cardiovascular exercise

Device: PPG during exercise

Interventions

PPG during exerciseDEVICE

PPG use for pulse waveform evaluation of healthy exercise group

PPG Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to understand consent (no proxy consent) in English or Chinese.
  • Self-Reported ability to undertake a 20 minute cycling activity at 60-70% exercise intensity.
  • 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.

You may not qualify if:

  • Inability to finish a 20 min cycling activity in 60-70% exercise intensity.
  • Adverse reaction to adhesive tape.
  • Raynaud's phenomenon
  • Angina or recent myocardial infarction (previous 6 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, 106, Taiwan

Location

Study Officials

  • Ka-Kit Hui, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 30, 2018

Study Start

May 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

December 10, 2020

Record last verified: 2020-12

Locations

TW(1)