Circulation and Oxygenation Changes of Deep Tissue Respond on LLLT

June 21, 2021 updated by: Ting Li

Circulation and Oxygenation Changes of Deep Tissue Respond on Low Level Light/Laser Therapy (LLLT) in the Healthy Population

This study aims to investigate the circulation and oxygenation changes of deep tissue respond on low level light/laser therapy (LLLT) in the healthy population. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to noninvasively monitor hemodynamic indicators of brain and forearm muscle groups, including total hemoglobin ([tHb]), and blood flow (BF) and oxygen consumption (VO2).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Low level light/laser therapy (LLLT) employs visible or near-infrared light generated from a laser or light emitting diode (LED) system. It has beneficial effects on a wide range of disease, including improving wound healing, reducing pain, improving memory, treat cancer, and many other human applications. This study aims to investigate the circulation and oxygenation changes of deep tissue respond on low level light/laser therapy (LLLT) in the healthy population. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to noninvasively monitor hemodynamic indicators of brain and forearm muscle groups, including total hemoglobin ([tHb]), and blood flow (BF) and oxygen consumption (VO2). Then the investigators concluded the effect of LLLT, according to compare the difference between the experimental group and control group.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • NIRS assessment for brain death

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy participants with no strenuous exercise or alcohol consumption prior to the test

Exclusion Criteria:

  • having risk factors associated with cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy experimental participants

The participants sat in a a quiet and darkened room with the upper arm at heart level and the forearm in an upward angle of 30°, 15-20 min prior to the experiment.

The experiments consists of 5-min rest, 90s inflated wrist cuff (240 mmHg) with 30s VO(one minute later), 3-min rest, 10-min intervention, the same 4.5-min process of the wrist cuff, VO and rest.

Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy probes of tow wavelengths were attached on the participants' forearm and brain to detect the changes of hemodynamic parameters.
Procedure: Low-Level Laser Therapy
Use 810-nm-photosource to irradiate the participants' brain and forearm for 10 minutes with a water-cooling radiator to keep it at 25 ± 0.5 ℃.
No Intervention: Healthy controlled participants

The participants sat in a a quiet and darkened room with the upper arm at heart level and the forearm in an upward angle of 30°, 15-20 min prior to the experiment.

The experiments consists of 5-min rest, 90s inflated wrist cuff (240 mmHg) with 30s VO(one minute later), 3-min rest, 10-min rest, the same 4.5-min process of the wrist cuff, VO and rest.

Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy probes of tow wavelengths were attached on the participants' forearm and brain to detect the changes of hemodynamic parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Δ[HbO2]
Time Frame: through study completion, an average of 1 year
changes of oxyhemoglobin concentration
through study completion, an average of 1 year
Δ[Hb]
Time Frame: through study completion, an average of 1 year
changes of deoxy-hemoglobin concentration
through study completion, an average of 1 year
Δ[tHb]
Time Frame: through study completion, an average of 1 year
changes of total hemoglobin concentration
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subcutaneous fat thickness
Time Frame: through study completion, an average of 1 year
the subcutaneous fat thickness of the forearm
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ting Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 25, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 21, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Deep Optical Theranastics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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