NCT05619133

PBM Effects on Health and Well-being in Humans

Effects and Underlying Mechanisms of Photobiomodulation (PBM) on Health and Well-Being

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Seaborough Life Science B.V. · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical study is to assess the effects of different photobiomodulation (PBM) conditions in men and women between 25 and 65 years old with daytime sleepiness/drowsiness and /or mild mood complaints but be otherwise healthy. The main question it aims to answer are: 1. Does PBM significantly affect health and well-being? 2. Are PBM effects wavelength dependent? 3. Are PBM effects pulse dependent? 4. Are the eyes needed to assert an PBM effect or is exposure only to the skin sufficient? 5. What are the cellular, metabolic pathways underlying the systemic effects of PBM. Participants will have to: 1. Exposed themselves 5 times per week during 2 weeks to the PBM stimuli between 9:30 and 12:30. 2. A week before the baseline measurement, participants will have to start wearing a Fitbit Versa 3, and will have to continuously wear until the end of the study. 3. In the afternoon of the baseline day as well as in the afternoons after 5 and 10 PBM sessions (week 1 and week 2, respectively), participants will have to go to the lab for blood withdraw. 4. In the evening of the baseline day as well as in the evenings after 5 and 10 PBM sessions (week 1 and week 2, respectively), participants will have to collect saliva samples as well as to complete questionnaires. It will be a double-blind placebo-controlled field study with a between subject comparison.

Detailed description

Five conditions (groups) will be tested: Dose (J.cm-2) Wavelength (nm) Pulse (Hz,ms) Duty factor Area Cond 1 6.5 850 15, 8 12% Skin + eyes Cond 2 6.5 940 15, 8 12% Skin + eyes Cond 3 6.5 850 100, 1 12% Skin + eyes Cond 4 0 850 15, 8 12% Skin + eyes Cond 5 6.5 850 15, 8 12% Skin

Conditions

• Sleep Deprivation
• Circadian Rhythm Disorders

Interventions

Type	Name	Description
DEVICE	PBM	In this study, the health benefits of the addition of NIR to the light spectrum of a desk lamp already available in the market will be investigate; Ikea Ypeperlig, to which a module with high power Lumileds NIR-Leds will be attached with beam angle of 90 degrees. They will be attached in such a way that, when the lamp is installed in the right place, a 1sr beam that covers the users face, neck and hands and lower arms on the desk with the required intensity of 5mW/cm2 of NIR at the skin surface. The device will be equipped with 3 sensors: 1. A distance sensor connected to the driver of the NIR-leds, such that when the user leans forward or backward, the intensity of the NIR is automatically adjusted such that the intensity on the skin remains 5mW/cm2 (see figure below). 2. a presence sensor 3. ambient vertical lux sensor by which amount of light that enters the users' eye will be measured since it is known that these have an effect sleep, mood and performance.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2022-11-16
• Last updated: 2022-11-16