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Clinical Trials/NCT03725189
NCT03725189
Completed
Not Applicable

Pilot Study of the Effect of Physical Activity on Pulse Waveform Monitored by a Novel Photophlethysmographic Device

University of California, Los Angeles1 site in 1 country42 target enrollmentMay 1, 2019
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of California, Los Angeles
Enrollment
42
Locations
1
Primary Endpoint
Harmonic measures (C1-C10) by PPG device
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
December 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kakit P. Hui, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Harmonic measures (C1-C10) by PPG device

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

C1-C10 by PPG device

Secondary Outcomes

  • Demographic Information(Day 1)
  • Diastolic blood pressure (DBP)(70 minutes on Day 1 for resting, exercise, and cool down measurements)
  • Heart rate and Heart Rate Variation(70 minutes on Day 1 for resting, exercise, and cool down measurements)
  • Height(Day 1)
  • Body mass index (BMI)(Day 1)
  • Systolic blood pressure (SBP)(70 minutes on Day 1 for resting, exercise, and cool down measurements)
  • HRV measures (SDNN, HF, LF and HF/LF parameters)(70 minutes on Day 1 for resting, exercise, and cool down measurements)
  • General health(Day 1)
  • Weight(Day 1)

Study Sites (1)

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