Low Level Light/Laser TherapyNCT04936165
Circulation and Oxygenation Changes of Deep Tissue Respond on LLLT
A study testing Low-Level Laser Therapy in people with Low Level Light/Laser Therapy and Near Infrared Spectroscopy, run by Ting Li at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Level Light/Laser Therapy, Near Infrared Spectroscopy
- What is being tested?
- Low-Level Laser Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants with no strenuous exercise or alcohol consumption prior to the test
Who cannot join
- having risk factors associated with cardiovascular disease
Trial locations and contacts
1 site in 1 country.
China1 site
NIRS assessment for brain death
Tianjin, Tianjin Municipality, 300000
About this study
Official title: 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).
Read the 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.
- Being tested
- Low-Level Laser Therapy
- Keywords
- Low level light/laser therapy, Near infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser TherapyProcedure or surgery
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 ℃.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Δ[HbO2]
changes of oxyhemoglobin concentration
Measured: through study completion, an average of 1 year
Δ[Hb]
changes of deoxy-hemoglobin concentration
Measured: through study completion, an average of 1 year
Δ[tHb]
changes of total hemoglobin concentration
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Subcutaneous fat thickness
the subcutaneous fat thickness of the forearm
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start25 Jun 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Level Light/Laser TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ting Li
- Responsible party
- Sponsor-investigator, Ting Li, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936165
- Sponsor's protocol ID
- Deep Optical Theranastics
- Status last verified
- Feb 2021
- First submitted
- 9 Nov 2020
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulation and Oxygenation Changes of Deep Tissue Respond on Low Level Light/Laser Therapy (LLLT) in the Healthy Population
- ClinicalTrials.gov ID
- NCT04936165
- Acronym / sponsor ID
- Deep Optical Theranastics
- Keywords
- Low level light/laser therapy, Near infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ting Li
- Study start
- 25 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy experimental participants | Experimental | Procedure: Low-Level Laser TherapyThe 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. |
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy participants with no strenuous exercise or alcohol consumption prior to the test
Key exclusion criteria (1 listed)
- having risk factors associated with cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Laser TherapyUse 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 ℃. | Procedure or surgery | Healthy experimental participants |
Primary outcome
Δ[HbO2]
Time frame: through study completion, an average of 1 year
changes of oxyhemoglobin concentration
Δ[Hb]
Time frame: through study completion, an average of 1 year
changes of deoxy-hemoglobin concentration
Δ[tHb]
Time frame: through study completion, an average of 1 year
changes of total hemoglobin concentration
1 secondary outcome
Subcutaneous fat thickness
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy in people with Low Level Light/Laser Therapy and Near Infrared Spectroscopy, run by Ting Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Δ[HbO2] (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.