InsomniaNCT07764107
Photobiomodulation for Reducing Sedative-Hypnotic Use:Clinical Trial of a Light-Therapy Device
A study testing PBM intervention in people with Insomnia, run by National Health Research Institutes, Taiwan.
Trial summary
Background: Insomnia is a prevalent and growing public health issue, with one in three adults affected globally and one in five Taiwanese adults reporting significant sleep disturbances. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Insomnia
- What is being tested?
- PBM intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 5 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A Pittsburgh Sleep Quality Index (PSQI) score of 8 or above.
- Currently taking sedative-hypnotic medications at least 4 days per week.
Who cannot join
- Having a movement disorder, including Parkinson's disease or moderate to severe dementia, resulting in inability to ambulate independently.
- Having major psychiatric comorbidities, such as bipolar disorder or schizophrenia, or a Beck Depression Inventory-II (BDI-II) score greater than 13.
- A history of sleep disorders, such as obstructive sleep apnea or periodic limb movement disorder.
- Currently undergoing adjustment of sleep medications in clinical care.
- Skin damage or active dermatologic conditions at the irradiation site.
- Night-shift workers or individuals unable to maintain regular nighttime sleep for other reasons.
- Pregnant women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Photobiomodulation for Reducing Sedative-Hypnotic Use: Clinical Trial of a Light-Therapy Device
Background: Insomnia is a prevalent and growing public health issue, with one in three adults affected globally and one in five Taiwanese adults reporting significant sleep disturbances. Long-term use of sedative-hypnotic medications remains common in Taiwan despite clinical guidelines recommending short-term use only, contributing to adverse outcomes such as impaired sleep architecture, cognitive deficits, and elevated dementia risk. Non-pharmacological interventions-particularly light-based therapies-offer promising alternatives but existing bright-light therapy is limited by melatonin suppression and the need for precise daytime timing. Recent advances in photobiomodulation (PBM) suggest that red and near-infrared light, which do not suppress melatonin, may enhance sleep quality and support glymphatic clearance when applied during sleep. Preliminary findings from our prior NSTC-funded industry-academia project demonstrated that 850-nm PBM applied during sleep improved subjective sleep quality and sleep duration among older adults with insomnia who were not using hypnotics. Building on these results, the present study aims to evaluate whether sleep-period PBM can improve sleep quality, enhance daytime alertness and cognitive function, and reduce sedative-hypnotic medication use among adults with chronic insomnia who regularly use these medications.
Methods: The study will employ an 8-week, single-blind, randomized controlled trial with two parallel arms: (1) PBM intervention and (2) inactive sham control. We will develop an engineer-certified wearable PBM prototype integrating near-infrared LEDs. Sixty adults who use sedative-hypnotics ≥4 days per week will be recruited. Participants will be randomized in a 1:1 ratio and instructed to use the assigned device applied at acupoints Ex-HN 22 continuously during the sleep period. Outcomes will be assessed at baseline, week 4, and week 8. Primary outcomes include changes in subjective sleep quality (PSQI), hypnotic use frequency, and objective sleep parameters measured by wrist actigraphy. Secondary outcomes include daytime sleepiness (KSS), emotional symptoms (BDI and BAI), and psychomotor vigilance task performance.
Expected contributions: This study is expected to generate clinical evidence in Taiwan evaluating nighttime PBM for insomnia in hypnotic-using populations, address the unmet need for portable, home-based, non-pharmacological sleep interventions, and support future commercialization of a sleep-compatible light therapy device. Results will inform device optimization, regulatory approval strategies, and market expansion efforts in the growing global sleep-health industry.
- Conditions
- Insomnia
- Being tested
- PBM intervention, Inactive sham control
- 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.
PBM interventionDevice
use the assigned device applied at acupoints Ex-HN 22 continuously during the sleep period
Inactive sham controlDevice
use the assigned device applied at acupoints Ex-HN 22 continuously during the sleep period
| Study group | Role | What they receive |
|---|---|---|
| PBM intervention | Experimental | Not described Receives: Device: PBM intervention; Device: Inactive sham control |
| Inactive sham control | Sham comparator | Not described Receives: Device: Inactive sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse). The assessment comprises seven dimensions, each with a score range of 0 to 3. The final PSQI score is the sum of the scores from all seven dimensions. A PSQI score of 5 or higher indicates a sleep quality disorder, with higher scores indicating poorer sleep quality.
Measured: baseline, week 4, and week 8
Hypnotic use frequency
Measured: baseline, week 4, and week 8
Actigraphy
Measured: baseline, week 4, and week 8
Secondary outcomes (1)
Daytime sleepiness
Epworth Sleepiness Scale ranges from 0 (better) to 24 (worse)
Measured: baseline, week 4, and week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion5 May 2027 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764107
- Sponsor's protocol ID
- NHRI
- Status last verified
- May 2026
- First submitted
- 9 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation for Reducing Sedative-Hypnotic Use: Clinical Trial of a Light-Therapy Device
- ClinicalTrials.gov ID
- NCT07764107
- Acronym / sponsor ID
- NHRI
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 13 Aug 2026 (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.
Background: Insomnia is a prevalent and growing public health issue, with one in three adults affected globally and one in five Taiwanese adults reporting significant sleep disturbances. Long-term use of sedative-hypnotic medications remains common in Taiwan despite clinical guidelines recommending short-term use only, contributing to adverse outcomes such as impaired sleep architecture, cognitive deficits, and elevated dementia risk. Non-pharmacological interventions-particularly light-based therapies-offer promising alternatives but existing bright-light therapy is limited by melatonin suppression and the need for precise daytime timing. Recent advances in photobiomodulation (PBM) suggest that red and near-infrared light, which do not suppress melatonin, may enhance sleep quality and support glymphatic clearance when applied during sleep. Preliminary findings from our prior NSTC-funded industry-academia project demonstrated that 850-nm PBM applied during sleep improved subjective sleep quality and sleep duration among older adults with insomnia who were not using hypnotics. Building on these results, the present study aims to evaluate whether sleep-period PBM can improve sleep quality, enhance daytime alertness and cognitive function, and reduce sedative-hypnotic medication use among adults with chronic insomnia who regularly use these medications.
Methods: The study will employ an 8-week, single-blind, randomized controlled trial with two parallel arms: (1) PBM intervention and (2) inactive sham control. We will develop an engineer-certified wearable PBM prototype integrating near-infrared LEDs. Sixty adults who use sedative-hypnotics ≥4 days per week will be recruited. Participants will be randomized in a 1:1 ratio and instructed to use the assigned device applied at acupoints Ex-HN 22 continuously during the sleep period. Outcomes will be assessed at baseline, week 4, and week 8. Primary outcomes include changes in subjective sleep quality (PSQI), hypnotic use frequency, and objective sleep parameters measured by wrist actigraphy. Secondary outcomes include daytime sleepiness (KSS), emotional symptoms (BDI and BAI), and psychomotor vigilance task performance.
Expected contributions: This study is expected to generate clinical evidence in Taiwan evaluating nighttime PBM for insomnia in hypnotic-using populations, address the unmet need for portable, home-based, non-pharmacological sleep interventions, and support future commercialization of a sleep-compatible light therapy device. Results will inform device optimization, regulatory approval strategies, and market expansion efforts in the growing global sleep-health industry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBM intervention | Experimental | Device: PBM intervention, Device: Inactive sham control |
| Inactive sham control | Sham comparator | Device: Inactive sham control |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A Pittsburgh Sleep Quality Index (PSQI) score of 8 or above.
- Currently taking sedative-hypnotic medications at least 4 days per week.
Key exclusion criteria (7 listed)
- Having a movement disorder, including Parkinson's disease or moderate to severe dementia, resulting in inability to ambulate independently.
- Having major psychiatric comorbidities, such as bipolar disorder or schizophrenia, or a Beck Depression Inventory-II (BDI-II) score greater than 13.
- A history of sleep disorders, such as obstructive sleep apnea or periodic limb movement disorder.
- Currently undergoing adjustment of sleep medications in clinical care.
- Skin damage or active dermatologic conditions at the irradiation site.
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 |
|---|---|---|
| PBM interventionuse the assigned device applied at acupoints Ex-HN 22 continuously during the sleep period | Device | PBM intervention |
| Inactive sham controluse the assigned device applied at acupoints Ex-HN 22 continuously during the sleep period | Device | Inactive sham control, PBM intervention |
Primary outcome
Sleep quality
Time frame: baseline, week 4, and week 8
Pittsburgh Sleep Quality Index (PSQI) ranges from 0 (better) to 21 (worse). The assessment comprises seven dimensions, each with a score range of 0 to 3. The final PSQI score is the sum of the scores from all seven dimensions. A PSQI score of 5 or higher indicates a sleep quality disorder, with higher scores indicating poorer sleep quality.
Hypnotic use frequency
Time frame: baseline, week 4, and week 8
Actigraphy
Time frame: baseline, week 4, and week 8
1 secondary outcome
Daytime sleepiness
Time frame: baseline, week 4, and week 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PBM intervention in people with Insomnia, run by National Health Research Institutes, 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 7 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wan-Ju Cheng Ph.D (+886975682566, s871065@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: baseline, week 4, and week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.