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| Name | Class |
|---|---|
| Chrono@Work B.V. | UNKNOWN |
| University of Groningen | OTHER |
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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:
Participants will have to:
It will be a double-blind placebo-controlled field study with a between subject comparison.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | No Intervention | No PBM will be emitted from the device; dose: 0 J.cm-2 | |
| PBM High standard | Experimental | A PBM high standard dose of 6.5 J.cm-2 with a wavelength of 850 nm, a pulse of 15 Hz and 8 ms and duty factor of 12% |
|
| PBM High wavelength | Experimental | A PBM high dose of 6.5 J.cm-2 with a wavelength of 940 nm, a pulse of 15 Hz and 8 ms and duty factor of 12% |
|
| PBM High pulse | Experimental | A PBM high dose of 6.5 J.cm-2 with a wavelength of 850 nm, a pulse of 100 Hz and 1.2 ms and duty factor of 12% |
|
| PBM High skin only | Experimental | A PBM high standard dose of 6.5 J.cm-2 with a wavelength of 850 nm, a pulse of 15 Hz and 8 ms and duty factor of 12%, but in this case the participants will wear filtering googles which will not allow PBM from entering the eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBM | Device | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in subjective mood after 5 and after 10 PBM sessions | Mood VAS scale, 0-10, higher score means better | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in subjective drowsiness after 5 and after 10 PBM sessions | Epworth Sleepiness Scale, 0-24, higher score means worse | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in depressions scale after 5 and after 10 PBM sessions | Beck Depression Inventory Second Edition, 0-63, higher score means worse | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in general activation after 5 and after 10 PBM sessions | Activation-Deactivation check list, 5-20, higher score means better | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in deactivation after 5 and after 10 PBM sessions | Activation-Deactivation check list, 11-14, higher score means worse | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in high activation after 5 and after 10 PBM sessions | Activation-Deactivation check list, 5-20, higher score means worse | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in general deactivation after 5 and after 10 PBM sessions | Activation-Deactivation check list, 5-20, higher score means worse |
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Inclusion Criteria:
Healthy, no chronic disease
Exclusion Criteria:
Depressive mood (BDI -II > 20)
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| Name | Affiliation | Role |
|---|---|---|
| Marijke Gordijn, PhD | Chrono@Work | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chrono@Work | Groningen | 9743 AD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20842007 | Result | Fulop AM, Dhimmer S, Deluca JR, Johanson DD, Lenz RV, Patel KB, Douris PC, Enwemeka CS. A meta-analysis of the efficacy of laser phototherapy on pain relief. Clin J Pain. 2010 Oct;26(8):729-36. doi: 10.1097/AJP.0b013e3181f09713. | |
| 32464190 | Result | Heiskanen V, Pfiffner M, Partonen T. Sunlight and health: shifting the focus from vitamin D3 to photobiomodulation by red and near-infrared light. Ageing Res Rev. 2020 Aug;61:101089. doi: 10.1016/j.arr.2020.101089. Epub 2020 May 25. |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D021081 | Chronobiology Disorders |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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|
| Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in subjective sleep quality scores after 5 and after 10 PBM sessions | Pittsburgh Sleep quality scale, 0-21, higher score means worse | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in resting heart rate after 5 and after 10 PBM sessions | Fitbit Versa 3 | Through study completion |
| Change from baseline in objective sleep quality scores after 5 and after 10 PBM sessions | Fitbit Versa 3 | Through study completion |
| Change from baseline in IFN- gamma concentrations after 5 and after 10 PBM sessions | Blood | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in TNF-alpha concentrations after 5 and after 10 PBM sessions | Blood | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in TGF-beta1concentrations after 5 and after 10 PBM sessions | Blood | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in il-1 concentrations after 5 and after 10 PBM sessions | Blood | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in il-6 concentrations after 5 and after 10 PBM sessions | Blood | Baseline, after 2 weeks, after 4 weeks |
| Shift from baseline in dim light melatonin onset after 5 and after 10 PBM sessions | Saliva | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in cortisol levels at bedtime after 5 and after 10 PBM sessions | Saliva | Baseline, after 2 weeks, after 4 weeks |
| Change from baseline in targeted metabolomics concentration after 5 and after 10 PBM sessions | Blood | Baseline, after 4 weeks |
| 33269093 | Result | Liebert A, Bicknell B, Markman W, Kiat H. A Potential Role for Photobiomodulation Therapy in Disease Treatment and Prevention in the Era of COVID-19. Aging Dis. 2020 Dec 1;11(6):1352-1362. doi: 10.14336/AD.2020.0901. eCollection 2020 Dec. |
| 33156403 | Result | Miranda-Silva W, Gomes-Silva W, Zadik Y, Yarom N, Al-Azri AR, Hong CHL, Ariyawardana A, Saunders DP, Correa ME, Arany PR, Bowen J, Cheng KKF, Tissing WJE, Bossi P, Elad S; Mucositis Study Group of the Multinational Association of Supportive Care in Cancer / International Society for Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis: sub-analysis of current interventions for the management of oral mucositis in pediatric cancer patients. Support Care Cancer. 2021 Jul;29(7):3539-3562. doi: 10.1007/s00520-020-05803-4. Epub 2020 Nov 6. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |