Back to resultsPBM Effects on Health and Well-being in Humans
Primary Purpose
Sleep Deprivation, Circadian Rhythm Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PBM
Sponsored by
About this trial
This is an interventional basic science trial for Sleep Deprivation
Eligibility Criteria
Inclusion Criteria: Healthy, no chronic disease Age between 25 - 65 years. Suffer from daytime sleepiness/drowsiness and or a mild mood disturbance (ESS >5 or BDI equal to or higher than 13 but lower than 20, PSQI > 5) Participants will have to have a desk type of work and/or have 3 hours per day between 9:30 am and 12:30 at their office/home in which they could sit in front of the lamp. Exclusion Criteria: Depressive mood (BDI -II > 20) Pregnancy Menopause symptoms Drug use during the last three months known to interfere with sleep, alertness, the biological clock and/or light sensitivity (i.e. regular usage of sleep medication or stimulating substances) Use of immune suppressants. High levels of caffeine intake during a day (5 or more cups, according to https://www.voedingscentrum.nl/encyclopedie/cafeine.aspx#blok7, there are no negative effects expected from 4 caffeine products in normal adults) High alcohol intake (more than 4 for men and more than 3 for women, drinks per day) for more than 5 days in the past month, including binge drinking and heavy drinking according to https://www.niaaa.nih.gov/publications/brochures-and- fact-sheets/alcohol-facts-and-statistics. Participant is not able to refrain from using recreational drugs during the 4 weeks of the study. Shift work schedule in the 3 months prior to participation and/or planned during the 2 weeks of the study Environmental factors in everyday life that may disturb sleep and cannot be prohibited (e.g. young children, noisy environment) Travel over 2 or more time zones in the month prior to participation Travel to sunny holiday locations/wintersports 1 month before participation Personal plans that prevent them for using the intervention during 2 consecutive weeks
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
No Intervention
Experimental
Experimental
Experimental
Experimental
Arm Label
placebo
PBM High standard
PBM High wavelength
PBM High pulse
PBM High skin only
Arm Description
No PBM will be emitted from the device; dose: 0 J.cm-2
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%
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%
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%
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
Outcomes
Primary Outcome Measures
Change from baseline in subjective mood after 5 and after 10 PBM sessions
Mood VAS scale, 0-10, higher score means better
Change from baseline in subjective drowsiness after 5 and after 10 PBM sessions
Epworth Sleepiness Scale, 0-24, higher score means worse
Change from baseline in depressions scale after 5 and after 10 PBM sessions
Beck Depression Inventory Second Edition, 0-63, higher score means worse
Change from baseline in general activation after 5 and after 10 PBM sessions
Activation-Deactivation check list, 5-20, higher score means better
Change from baseline in deactivation after 5 and after 10 PBM sessions
Activation-Deactivation check list, 11-14, higher score means worse
Change from baseline in high activation after 5 and after 10 PBM sessions
Activation-Deactivation check list, 5-20, higher score means worse
Change from baseline in general deactivation after 5 and after 10 PBM sessions
Activation-Deactivation check list, 5-20, higher score means worse
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
Change from baseline in resting heart rate after 5 and after 10 PBM sessions
Fitbit Versa 3
Change from baseline in objective sleep quality scores after 5 and after 10 PBM sessions
Fitbit Versa 3
Change from baseline in IFN- gamma concentrations after 5 and after 10 PBM sessions
Blood
Change from baseline in TNF-alpha concentrations after 5 and after 10 PBM sessions
Blood
Change from baseline in TGF-beta1concentrations after 5 and after 10 PBM sessions
Blood
Change from baseline in il-1 concentrations after 5 and after 10 PBM sessions
Blood
Change from baseline in il-6 concentrations after 5 and after 10 PBM sessions
Blood
Shift from baseline in dim light melatonin onset after 5 and after 10 PBM sessions
Saliva
Change from baseline in cortisol levels at bedtime after 5 and after 10 PBM sessions
Saliva
Change from baseline in targeted metabolomics concentration after 5 and after 10 PBM sessions
Blood
Secondary Outcome Measures
Full Information
NCT ID
NCT05619133
First Posted
November 1, 2022
Last Updated
November 8, 2022
Sponsor
Seaborough Life Science B.V.
Collaborators
Chrono@Work B.V., University of Groningen
1. Study Identification
Unique Protocol Identification Number
NCT05619133
Brief Title
PBM Effects on Health and Well-being in Humans
Official Title
Effects and Underlying Mechanisms of Photobiomodulation (PBM) on Health and Well-Being
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seaborough Life Science B.V.
Collaborators
Chrono@Work B.V., University of Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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:
Does PBM significantly affect health and well-being?
Are PBM effects wavelength dependent?
Are PBM effects pulse dependent?
Are the eyes needed to assert an PBM effect or is exposure only to the skin sufficient?
What are the cellular, metabolic pathways underlying the systemic effects of PBM.
Participants will have to:
Exposed themselves 5 times per week during 2 weeks to the PBM stimuli between 9:30 and 12:30.
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.
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Circadian Rhythm Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
No Intervention
Arm Description
No PBM will be emitted from the device; dose: 0 J.cm-2
Arm Title
PBM High standard
Arm Type
Experimental
Arm Description
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%
Arm Title
PBM High wavelength
Arm Type
Experimental
Arm Description
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%
Arm Title
PBM High pulse
Arm Type
Experimental
Arm Description
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%
Arm Title
PBM High skin only
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
PBM
Intervention Description
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:
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).
a presence sensor
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.
Primary Outcome Measure Information:
Title
Change from baseline in subjective mood after 5 and after 10 PBM sessions
Description
Mood VAS scale, 0-10, higher score means better
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in subjective drowsiness after 5 and after 10 PBM sessions
Description
Epworth Sleepiness Scale, 0-24, higher score means worse
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in depressions scale after 5 and after 10 PBM sessions
Description
Beck Depression Inventory Second Edition, 0-63, higher score means worse
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in general activation after 5 and after 10 PBM sessions
Description
Activation-Deactivation check list, 5-20, higher score means better
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in deactivation after 5 and after 10 PBM sessions
Description
Activation-Deactivation check list, 11-14, higher score means worse
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in high activation after 5 and after 10 PBM sessions
Description
Activation-Deactivation check list, 5-20, higher score means worse
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in general deactivation after 5 and after 10 PBM sessions
Description
Activation-Deactivation check list, 5-20, higher score means worse
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in subjective sleep quality scores after 5 and after 10 PBM sessions
Description
Pittsburgh Sleep quality scale, 0-21, higher score means worse
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in resting heart rate after 5 and after 10 PBM sessions
Description
Fitbit Versa 3
Time Frame
Through study completion
Title
Change from baseline in objective sleep quality scores after 5 and after 10 PBM sessions
Description
Fitbit Versa 3
Time Frame
Through study completion
Title
Change from baseline in IFN- gamma concentrations after 5 and after 10 PBM sessions
Description
Blood
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in TNF-alpha concentrations after 5 and after 10 PBM sessions
Description
Blood
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in TGF-beta1concentrations after 5 and after 10 PBM sessions
Description
Blood
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in il-1 concentrations after 5 and after 10 PBM sessions
Description
Blood
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in il-6 concentrations after 5 and after 10 PBM sessions
Description
Blood
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Shift from baseline in dim light melatonin onset after 5 and after 10 PBM sessions
Description
Saliva
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in cortisol levels at bedtime after 5 and after 10 PBM sessions
Description
Saliva
Time Frame
Baseline, after 2 weeks, after 4 weeks
Title
Change from baseline in targeted metabolomics concentration after 5 and after 10 PBM sessions
Description
Blood
Time Frame
Baseline, after 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, no chronic disease
Age between 25 - 65 years.
Suffer from daytime sleepiness/drowsiness and or a mild mood disturbance (ESS >5 or BDI equal to or higher than 13 but lower than 20, PSQI > 5)
Participants will have to have a desk type of work and/or have 3 hours per day between 9:30 am and 12:30 at their office/home in which they could sit in front of the lamp.
Exclusion Criteria:
Depressive mood (BDI -II > 20)
Pregnancy
Menopause symptoms
Drug use during the last three months known to interfere with sleep, alertness, the biological clock and/or light sensitivity (i.e. regular usage of sleep medication or stimulating substances)
Use of immune suppressants. High levels of caffeine intake during a day (5 or more cups, according to https://www.voedingscentrum.nl/encyclopedie/cafeine.aspx#blok7, there are no negative effects expected from 4 caffeine products in normal adults)
High alcohol intake (more than 4 for men and more than 3 for women, drinks per day) for more than 5 days in the past month, including binge drinking and heavy drinking according to https://www.niaaa.nih.gov/publications/brochures-and- fact-sheets/alcohol-facts-and-statistics.
Participant is not able to refrain from using recreational drugs during the 4 weeks of the study.
Shift work schedule in the 3 months prior to participation and/or planned during the 2 weeks of the study
Environmental factors in everyday life that may disturb sleep and cannot be prohibited (e.g. young children, noisy environment)
Travel over 2 or more time zones in the month prior to participation
Travel to sunny holiday locations/wintersports 1 month before participation
Personal plans that prevent them for using the intervention during 2 consecutive weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Gimenez, PhD
Phone
+31502111946
Email
marina.gimenez@chronoatwork.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Luxwolda, MSc
Phone
31502111946
Email
michelle.luxwolda@chronoatwork.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marijke Gordijn, PhD
Organizational Affiliation
Chrono@Work
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20842007
Citation
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.
Results Reference
result
PubMed Identifier
32464190
Citation
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.
Results Reference
result
PubMed Identifier
33269093
Citation
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.
Results Reference
result
PubMed Identifier
33156403
Citation
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.
Results Reference
result
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PBM Effects on Health and Well-being in Humans
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