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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04936165
Other study ID # Deep Optical Theranastics
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 25, 2021
Est. completion date December 31, 2021

Study information

Verified date February 2021
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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 ?.

Locations

Country Name City State
China NIRS assessment for brain death Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Ting Li

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary ?[HbO2] changes of oxyhemoglobin concentration through study completion, an average of 1 year
Primary ?[Hb] changes of deoxy-hemoglobin concentration through study completion, an average of 1 year
Primary ?[tHb] changes of total hemoglobin concentration through study completion, an average of 1 year
Secondary Subcutaneous fat thickness the subcutaneous fat thickness of the forearm through study completion, an average of 1 year
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