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Interventions

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Presenting the interventions of red and near-infrared light as applied in the present study's protocol will quickly beg answers to questions, which is as it should be.

The output from these lights will be directed at two regions of an enrollee's body: the head, and for some, the lower region of the chest in back as well.

 

Here are at least some of those questions which can be anticipated.

We'll take advantage of a "sister" site to respond to most, using links to information already offered elsewhere. 

 

      • Is it safe?
      • Has it ever been done before? Is this brand new and untested?
      • Has it ever proven to be effective?
      • What specific scientific characteristics of these lights are applied in this study?
      • Have these lights been used with COVID-19 patients?
      • Exactly how is an 'intervention' carried out?

 

For most of those questions, this Selected Bibliography is the right place to start.

A quick summary based on the peer-reviewed literature is that such intervention is safe, has been in use for about 40 years, has proven effective across a variety of medical domains, best summarized as healing and repair, and has been used in the present COVID-19 setting. In all of this, no undesirable side effects have been reported or described.

 

For some, shining a light on one's elbow might meet with less resistance than shining a light on one's head. While understandable, it is underscored here that when exactly that was done with helmets of red lights worn on and surrounding the head, these were carried out, and are still carried out, without reports of harmful sequelae.

 

This is also an appropriate place to address concerns about possible detrimental effects on vision. While similar devices are at times sold with black or obturating eyewear for "protection," this may be guided by thoughts that are more administrative and legal than scientific. A part of the present study includes assessment of visual acuity. On that page attention is drawn to numerous studies where red light in these wavelengths is used for retinal and optic nerve protection and repair. As an aside, blue, ultraviolet and even white light are concerning with respect to known potential eye damage. 

 

A more detailed response to appropraite questions is available as introduced through links on this site's landing page. But to provide that detail again here will only delay presentation of the specifics of our present interventions. These are clearly based in the prior art.

 

Useful specifics will next be presented.

 

  • A light in its supplied holder will be hand-held by enrollees, and moved around the head in a specific pattern, at a distance from the scalp of 1.25cm, and for specifically 10 minutes each day during days 1 to 20 of the study. The pattern of movement is shown in the gallery below, and will be demonstrated in a video (soon to be placed on this page).

 

The light is started above and behind the right ear (point 1), moves towards the front to reach and touch the right eyebrow (pt 6), is passed to the middle of the forehead (pt 7), moves straight back towards the back of the head (pt 12), is passed towards the left side in back (pt 13), then forwards until reaching the left eyebrow (pt 18). The left hand then passes the device to the right hand (pts 19 & 20) to reach pt 1 and repeating continuously the same path once again. An audio file is provided to help time and keep track of these movements during the 10 minutes. The lamp and its holder do not become hot.

 

Each light has been equipped with a central "bump" which serves as a distance reminder.

It measures 1.25cm in thickness. While 'massaging' one's head with this is not the idea, it serves as a frequent reminder of the distance between scalp and light to be maintained during this intervention. Why 1.25cm? Because for the specific and measured irradiance of these devices, over a 10 minute period they will supply an energy density of 40 Jouls/cm² which is the desired field strength. This value has often been reported in studies for indications as varied as traumatic brain injury to wound healing to retinal repair and orthopedic fracture healing.

 

For those enrollees randomized to the "Intervention +" subgroup in each arm of the study, a similar exposure will be carried out for 10 minutes, again at 1.25cm, but over the surface of the lower posterior thorax. (back of the chest, above the lower ribs, from left, to middle, to right side and back again). This, in addition to the cephalic (head) intervention. This determines a total of 20 minutes of light intervention per day for those in the "Intervention +" subgroup, during the 20 intervention days of the study.

 

This posterior thoracic intervention is represented in the gallery of images below, and will soon have both a video and an audio recording to assist participants. It has been selected as a region for the intervention, based on symptoms and findings commonly associated with COVID-19 infections and the "long-term" COVID-19 variant.

 

The images show the device supplied to enrollees, clamped to a simple chair back, a supplied pad on the chair designed to simplify left-to-right rotation, and a subject at the correct distance from the light.

 

 

So an enrollee's involvement is essentially divided in half. One part being the intervention for 20 days, and the second being subjective and objective measurements made to assess the effectiveness of the intervention. Neither activity will be of use for the study, unless measurements that have been made are transmitted for safekeeping and analysis. So that would represent a third vital category of enrollee activity.

 

 

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19/05/2021
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