Circulation and Oxygenation Changes of Deep Tissue Respond on LLLT

Not Applicable

• Conditions: Near Infrared Spectroscopy; Low Level Light/Laser Therapy
• Interventions: Procedure: Low-Level Laser Therapy

• Registration Number: NCT04936165
• Lead Sponsor: Ting Li

Brief Summary

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).

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 Timeline

• Study First Submitted: 2020-11-09
• Status Verified: 2021-02
• Study First Submitted QC: 2021-06-21
• Last Update Submitted: 2021-06-21
• Study First Posted: 2021-06-23
• Last Update Posted: 2021-06-23
• Study Start: 2021-06-25
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy experimental participants	Low-Level Laser Therapy	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.

Primary Outcome Measures

Name	Time	Method
Δ[tHb]	through study completion, an average of 1 year	changes of total hemoglobin concentration
Δ[Hb]	through study completion, an average of 1 year	changes of deoxy-hemoglobin concentration
Δ[HbO2]	through study completion, an average of 1 year	changes of oxyhemoglobin concentration

Secondary Outcome Measures

Name	Time	Method
Subcutaneous fat thickness	through study completion, an average of 1 year	the subcutaneous fat thickness of the forearm

Trial Locations

Locations (1)

NIRS assessment for brain death; 🇨🇳 Tianjin, Tianjin, China