- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07369843
LASER Effects Blood Flow (LASERBF)
Effects of Low Power LASER on the Heart Rate Variability of Human Subjects
This study investigate the potential impact of low power laser (LPL), an non-invasive physical therapy, on the cardiovascular system by focusing on its effect on heart rate and autonomic tone.
Study will recruit healthy volunteers and non-invasively monitor their electrocardiogram and digital pulse in response to LPL.
In addition, the potential involvement of autonomic tone will be clarify by topically applying gel (2% lidocaine gel)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study investigate the potential impact of low power laser (LPL), an non-invasive physical therapy, on the cardiovascular system by focusing on its effect on heart rate and autonomic tone.
Study will recruit healthy volunteers (age 20-60; having no diabetes, hypertension, or other medical problem) and non-invasively monitor their electrocardiogram and digital pulse in response to LPL (with an intensity for relieving pain).
In addition, the potential involvement of autonomic tone will be clarify by topically applying gel (2% lidocaine gel) at the site 2 cm distal to the applying site.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chun-Ming Hsieh, MS
- Phone Number: 8714 +886-(03)361-3141
- Email: tblin2@gmail.com
Study Contact Backup
- Name: Tzer-Bin Lin, Ph.D.
- Phone Number: +886-0935-972505
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age from 20-45
Exclusion Criteria:
- no medical history of diabetes, hypertension, or other medical problem
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: test effect
Control, experiment, and recovery data will be acquired for each volunteer
|
Low power laser with an intensity for pain relieving will be applied to volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
heart rate
Time Frame: Continuous heart rate (HR) recording will start when it is stable after a brief resting (10 min); maintained during stimulation (30 min), and lasted for a period until the HR recovers.
|
the heart rate before, during, and after low power LASER
|
Continuous heart rate (HR) recording will start when it is stable after a brief resting (10 min); maintained during stimulation (30 min), and lasted for a period until the HR recovers.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LASERBF1
- Saint Paul's Hospital (Other Identifier: Saint Paul's Hospital)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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