Sleep DeprivationNCT05619133
PBM Effects on Health and Well-being in Humans
A study testing PBM in people with Sleep Deprivation and Circadian Rhythm Disorders, run by Seaborough Life Science B.V. at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Circadian Rhythm Disorders
- What is being tested?
- PBM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2023to 1 Apr 2024
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects and Underlying Mechanisms of Photobiomodulation (PBM) on Health and Well-Being
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.
Read more
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.
Read the 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
- Being tested
- PBM
- Medical subject headings
- Sleep Deprivation, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: Device: PBM |
| 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% Receives: Device: PBM |
| 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% Receives: Device: PBM |
| 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 Receives: Device: PBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in subjective mood after 5 and after 10 PBM sessions
Mood VAS scale, 0-10, higher score means better
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, after 2 weeks, after 4 weeks
Change from baseline in resting heart rate after 5 and after 10 PBM sessions
Fitbit Versa 3
Measured: Through study completion
Change from baseline in objective sleep quality scores after 5 and after 10 PBM sessions
Fitbit Versa 3
Measured: Through study completion
Change from baseline in IFN- gamma concentrations after 5 and after 10 PBM sessions
Blood
Measured: Baseline, after 2 weeks, after 4 weeks
Change from baseline in TNF-alpha concentrations after 5 and after 10 PBM sessions
Blood
Measured: Baseline, after 2 weeks, after 4 weeks
Change from baseline in TGF-beta1concentrations after 5 and after 10 PBM sessions
Blood
Measured: Baseline, after 2 weeks, after 4 weeks
Change from baseline in il-1 concentrations after 5 and after 10 PBM sessions
Blood
Measured: Baseline, after 2 weeks, after 4 weeks
Change from baseline in il-6 concentrations after 5 and after 10 PBM sessions
Blood
Measured: Baseline, after 2 weeks, after 4 weeks
Shift from baseline in dim light melatonin onset after 5 and after 10 PBM sessions
Saliva
Measured: Baseline, after 2 weeks, after 4 weeks
Change from baseline in cortisol levels at bedtime after 5 and after 10 PBM sessions
Saliva
Measured: Baseline, after 2 weeks, after 4 weeks
Change from baseline in targeted metabolomics concentration after 5 and after 10 PBM sessions
Blood
Measured: Baseline, after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Jan 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seaborough Life Science B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chrono@Work B.V., University of Groningen
- Responsible party
- Sponsor
- Investigators
- Marijke Gordijn, PhD, Principal investigator, Chrono@Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619133
- Sponsor's protocol ID
- PBM2022
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2022
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20842007Heiskanen 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.
PubMed 32464190Liebert 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.
PubMed 33269093Miranda-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.
PubMed 33156403
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Underlying Mechanisms of Photobiomodulation (PBM) on Health and Well-Being
- ClinicalTrials.gov ID
- NCT05619133
- Acronym / sponsor ID
- PBM2022
- Conditions
- Sleep Deprivation, Circadian Rhythm Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seaborough Life Science B.V.Industry (pharma, biotech, devices)
- Collaborators
- Chrono@Work B.V., University of Groningen
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 16 Nov 2022 (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.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| placebo | No intervention | –No PBM will be emitted from the device; dose: 0 J.cm-2 |
| PBM High standard | Experimental | Device: PBMA 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 | Device: PBMA 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 | Device: PBMA 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 | Device: PBMA 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 |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
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 |
|---|---|---|
| PBMIn 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. | Device | PBM High pulse, PBM High skin only, PBM High standard, PBM High wavelength |
Primary outcome
Change from baseline in subjective mood after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Mood VAS scale, 0-10, higher score means better
Change from baseline in subjective drowsiness after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Epworth Sleepiness Scale, 0-24, higher score means worse
Change from baseline in depressions scale after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Beck Depression Inventory Second Edition, 0-63, higher score means worse
Change from baseline in general activation after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Activation-Deactivation check list, 5-20, higher score means better
Change from baseline in deactivation after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Activation-Deactivation check list, 11-14, higher score means worse
Change from baseline in high activation after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Activation-Deactivation check list, 5-20, higher score means worse
Change from baseline in general deactivation after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
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
Time frame: Baseline, after 2 weeks, after 4 weeks
Pittsburgh Sleep quality scale, 0-21, higher score means worse
Change from baseline in resting heart rate after 5 and after 10 PBM sessions
Time frame: Through study completion
Fitbit Versa 3
Change from baseline in objective sleep quality scores after 5 and after 10 PBM sessions
Time frame: Through study completion
Fitbit Versa 3
Change from baseline in IFN- gamma concentrations after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Blood
Change from baseline in TNF-alpha concentrations after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Blood
Change from baseline in TGF-beta1concentrations after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Blood
Change from baseline in il-1 concentrations after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Blood
Change from baseline in il-6 concentrations after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Blood
Shift from baseline in dim light melatonin onset after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Saliva
Change from baseline in cortisol levels at bedtime after 5 and after 10 PBM sessions
Time frame: Baseline, after 2 weeks, after 4 weeks
Saliva
Change from baseline in targeted metabolomics concentration after 5 and after 10 PBM sessions
Time frame: Baseline, after 4 weeks
Blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Results publication: PubMed 20842007Fulop 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 publication: PubMed 32464190Heiskanen 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 publication: PubMed 33269093Liebert 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 publication: PubMed 33156403Miranda-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.
- 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.
Marijke Gordijn, PhD principal investigator
Chrono@Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBM in people with Sleep Deprivation and Circadian Rhythm Disorders, run by Seaborough Life Science B.V. at 1 site in Netherlands.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 30 Apr 2026. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in subjective mood after 5 and after 10 PBM sessions (time frame: Baseline, after 2 weeks, after 4 weeks). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05619133, which also lists 4 linked publications.
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 30 Apr 2026.