Circulation and Oxygenation Changes of Deep Tissue Respond on LLLT

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: Near Infrared Spectroscopy; Low Level Light/Laser Therapy
• Intervention / Treatment: Procedure: Low-Level Laser Therapy

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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]	changes of oxyhemoglobin concentration	through study completion, an average of 1 year
Δ[Hb]	changes of deoxy-hemoglobin concentration	through study completion, an average of 1 year
Δ[tHb]	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	the subcutaneous fat thickness of the forearm	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Ting Li

Study record dates

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: Near infrared spectroscopy; Low level light/laser therapy
• 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