PhotobiomodulationNCT06292819
Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices
A study testing Bright light, Near-infrared light and Bright light+ near-infrared light in people with Photobiomodulation, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Photobiomodulation
- What is being tested?
- Bright light, Near-infrared light and Bright light+ near-infrared light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Apr 2024to 3 Oct 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pittsburgh Sleep Quality Index score is 8 or above.
- Early wakening ( 30 minutes before expected), or interruptted sleep for more than 30 minutes, lasting for more than 3 months.
Who cannot join
- Movement disorder, inability to move independently.
- Skin diseases, skin cancer, photosensitive skin diseases, or taking drugs that may cause photosensitivity (lithium salts, melatonin, antibiotics, A acid).
- Eye diseases such as glaucoma, diabetic retinopathy, and cataracts.
- Bipolar disorder.
- Light-induced epilepsy.
- Sleep disorders such as sleep apnea and involuntary leg twitching.
Show all 15Show fewer
- Currently taking sedative-hypnotic drugs or receiving other non-drug treatments.
- Beck depression inventory-II score is greater than 13 points.
- Those who use cardiac rhythm regulators or artificial cardiopulmonary pacemakers.
- Acute illness.
- Abnormal blood pressure or fever.
- Pregnancy and pregnant women.
- Special physical abnormalities and sensory nerve abnormalities.
- Infectious diseases.
- Coagulation disorder.
Trial locations and contacts
1 site in 1 country.
About this study
The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events.
- Conditions
- Photobiomodulation
- Being tested
- Bright light, Near-infrared light, Bright light+ near-infrared light
- Keywords
- rhythm; light therapy; insomnia; sleep; older
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright lightDevice
Bright light will use a 5000-10,000 Lux LED light source. Exposure is for 60 minutes daily, between 7pm and 9pm.
Near-infrared lightDevice
Near-infrared light will use a wavelength of 850nm and a dose range of 1 - 6.5 joules/cm2. It is fixed on the neck with a band, the light source contacts the back of the neck, and is used for 60 minutes before going to bed.
Bright light+ near-infrared lightDevice
After using the bright light device, then use the near-infrared light device on the back of the neck before going to bed.
| Study group | Role | What they receive |
|---|---|---|
| Bright light | Active comparator | Not described Receives: Device: Bright light |
| Near-infrared light | Active comparator | Not described Receives: Device: Near-infrared light |
| Bright light+ near-infrared light | Active comparator | Not described Receives: Device: Bright light+ near-infrared light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphy-derived sleep indicators
Participants will continue to wear activity recording watches during the three weeks of the study. We will capture weekly average sleep duration, sleep onset latency, wake time after falling asleep, and sleep efficiency.
Measured: Baseline and the third week.
Dim-light melatonin onset
Participants will be required to provide saliva samples for melatonin analysis within their home environment. These samples will be collected at 30-minute intervals starting from 18:00 and continuing until 1 hour after their habitual sleep time on both the initial and final study dates. The concentration of salivary melatonin will be assessed utilizing a direct melatonin enzyme-linked immunosorbent assay (ELISA) kit. The Dim Light Melatonin Onset (DLMO) will be determined using the two standard deviation threshold method, which involves calculating the average of the first three melatonin data points and then adding two standard deviations to this average.
Measured: Baseline and the third week.
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse).
Measured: Baseline and the third week.
Emotional state
Beck Depression Inventory-II ranges from 0 (better) to 63 (worse).
Measured: Baseline and the third week.
Secondary outcomes (1)
Daytime sleepiness
Epworth Sleepiness Scale ranges from 0 (better) to 24 (worse).
Measured: Baseline and the third week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start26 Apr 2024
- Primary completion31 Aug 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhotobiomodulationStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Ju Cheng, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292819
- Sponsor's protocol ID
- CMUH112-REC2-214
- Status last verified
- Nov 2025
- First submitted
- 17 Feb 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen PY, Chen ST, Chen YL, Yang YC, Cheng WJ. Effects of bright light and near-infrared light on insomnia symptoms in community-dwelling older adults: a randomized clinical trial. Photodiagnosis Photodyn Ther. 2026 Apr;58:105425. doi: 10.1016/j.pdpdt.2026.105425. Epub 2026 Mar 5.
PubMed 41794313
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices
- ClinicalTrials.gov ID
- NCT06292819
- Acronym / sponsor ID
- CMUH112-REC2-214
- Conditions
- Photobiomodulation
- Keywords
- rhythm; light therapy; insomnia; sleep; older
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 5 Mar 2024 (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 study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bright light | Active comparator | Device: Bright light |
| Near-infrared light | Active comparator | Device: Near-infrared light |
| Bright light+ near-infrared light | Active comparator | Device: Bright light+ near-infrared light |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pittsburgh Sleep Quality Index score is 8 or above.
- Early wakening ( 30 minutes before expected), or interruptted sleep for more than 30 minutes, lasting for more than 3 months.
Key exclusion criteria (15 listed)
- Movement disorder, inability to move independently.
- Skin diseases, skin cancer, photosensitive skin diseases, or taking drugs that may cause photosensitivity (lithium salts, melatonin, antibiotics, A acid).
- Eye diseases such as glaucoma, diabetic retinopathy, and cataracts.
- Bipolar disorder.
- Light-induced epilepsy.
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 |
|---|---|---|
| Bright lightBright light will use a 5000-10,000 Lux LED light source. Exposure is for 60 minutes daily, between 7pm and 9pm. | Device | Bright light |
| Near-infrared lightNear-infrared light will use a wavelength of 850nm and a dose range of 1 - 6.5 joules/cm2. It is fixed on the neck with a band, the light source contacts the back of the neck, and is used for 60 minutes before going to bed. | Device | Near-infrared light |
| Bright light+ near-infrared lightAfter using the bright light device, then use the near-infrared light device on the back of the neck before going to bed. | Device | Bright light+ near-infrared light |
Primary outcome
Actigraphy-derived sleep indicators
Time frame: Baseline and the third week.
Participants will continue to wear activity recording watches during the three weeks of the study. We will capture weekly average sleep duration, sleep onset latency, wake time after falling asleep, and sleep efficiency.
Dim-light melatonin onset
Time frame: Baseline and the third week.
Participants will be required to provide saliva samples for melatonin analysis within their home environment. These samples will be collected at 30-minute intervals starting from 18:00 and continuing until 1 hour after their habitual sleep time on both the initial and final study dates. The concentration of salivary melatonin will be assessed utilizing a direct melatonin enzyme-linked immunosorbent assay (ELISA) kit. The Dim Light Melatonin Onset (DLMO) will be determined using the two standard deviation threshold method, which involves calculating the average of the first three melatonin data points and then adding two standard deviations to this average.
Sleep quality
Time frame: Baseline and the third week.
Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse).
Emotional state
Time frame: Baseline and the third week.
Beck Depression Inventory-II ranges from 0 (better) to 63 (worse).
1 secondary outcome
Daytime sleepiness
Time frame: Baseline and the third week.
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 2 Dec 2025.
- Derived from this study: PubMed 41794313Chen PY, Chen ST, Chen YL, Yang YC, Cheng WJ. Effects of bright light and near-infrared light on insomnia symptoms in community-dwelling older adults: a randomized clinical trial. Photodiagnosis Photodyn Ther. 2026 Apr;58:105425. doi: 10.1016/j.pdpdt.2026.105425. Epub 2026 Mar 5.
- Individual participant dataSharing planned: No
Related trials for Photobiomodulation
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Not yet recruiting
Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke
Stroke
Not yet recruiting
Photobiomodulation for Cancer-Related Cognitive Impairment
Cancer-related Cognitive Impairment
RecruitingPhase 2
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
Graft-Versus-Host Disease, GVHD
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright light, Near-infrared light and Bright light+ near-infrared light in people with Photobiomodulation, run by China Medical University Hospital at 1 site in Taiwan.
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 2 inclusion and 15 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 2 Dec 2025. 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 Taiwan. 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?
Actigraphy-derived sleep indicators (time frame: Baseline and the third week.). The study lists 4 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 NCT06292819, which also lists 1 linked publication.
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 2 Dec 2025.