Circulation and Oxygenation Changes of Deep Tissue Respond on LLLT

NCT04936165 | Unknown

• 1 other identifier: Deep Optical Theranastics
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Low Level Light/Laser Therapy; Near Infrared Spectroscopy

Keywords

Low level light/laser therapy; Near infrared spectroscopy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Subcutaneous fat thickness

  through study completion, an average of 1 year

Study Arms (2)

Healthy experimental participants

EXPERIMENTAL

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

Healthy controlled participants

NO INTERVENTION

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.

Interventions

Low-Level Laser Therapy PROCEDURE

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 ℃.

Healthy experimental participants

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• having risk factors associated with cardiovascular disease

Sponsors & Collaborators

• Ting Li: lead

Study Sites (1)

NIRS assessment for brain death

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: June 23, 2021
• Study Start: June 25, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)