DepressionNCT07168954
Smart Light Therapy Glasses for Sleep and Mental Wellness
A study testing Lumos Glasses in people with Depression and Sleep Disturbance, run by University of Waterloo at 1 site in Canada.
Trial summary
A pair of smart light therapy glasses (Lumos Glasses) was engineered to control the amount of blue light exposure at a person's eyes through a battery powered light source and nano-coating that reflect blue light. The research aims to study the effects of this pair of light therapy glasses on depression and sleep. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Sleep Disturbance
- What is being tested?
- Lumos Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- 3 Sep 2024to 14 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults, any gender, 18+ years old, residing in Ontario Montgomery Asberg Depression Rating Scale Score > 7 or PROMIS score >25 Spend on average less than 2 hours outdoors daily.
Who cannot join
- MADRS Score above 45, or MADRS suicide score is 5 or 6 People with eye disorders or previous eye surgeries. People who have cataracts, macular degeneration, diabetic retinopathy, or other eye disorders. People taking light sensitizing medication. People with bipolar, psychotic disorders or a history of these disorders. People with epilepsy, or history of epilepsy. People with electronic implants, such as pacemakers. Prescription glasses wearers, except for people who can self-supply contact Page 6 of 40 lenses for the duration of the study. People who do not have an iOS or Android based smartphone Shift workers who work night shift or rotating shifts with night shifts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smart Light Therapy Glasses for Sleep and Mental Wellness, A Randomized Controlled Trial
A pair of smart light therapy glasses (Lumos Glasses) was engineered to control the amount of blue light exposure at a person's eyes through a battery powered light source and nano-coating that reflect blue light.
The research aims to study the effects of this pair of light therapy glasses on depression and sleep.
In addition, the research aims to study the effects of duration of use and its correlation with depression and sleep improvements.
Read the detailed description
Light has a fundamental impact on human biology. Bright light triggers photoreceptors at the back of the retina to induce neurobiological changes in the brain, affecting neurotransmitter levels such as melatonin and cortisol. For those struggling with depression and sleeping disorders, medical professionals generally recommend the use of a light therapy lamp for 30 minutes a day and the patient begins to improve within the first few weeks of use. However, due to the practical limitations of current light therapy devices such as lamps and head gears, longer durations (2 hours or more) of light therapy each day are often considered infeasible for a modern person, and even adherence to 30 minute are low. As such, the correlation of light therapy duration on sleep and mood improvements are not well understood. Due to this hardware limitation, many research efforts aim to study methods to reduce the duration of light therapy for practical benefits, leading to significant limitations and bias in the understanding of light therapy as well as its clinical implications.
From an alternate perspective of understanding, while the intensity of light from a light therapy box (5000 - 10 000 lux) is brighter than average indoor conditions (500 lux), it rarely exceeds the brightness of light from natural outdoors (up to 100 000 lux). And research also suggests that spending time outdoors could be just as effective as a method as light therapy in treating seasonal affective disorder. As such, it is possible that light therapy's role is to make up for a lack of natural light exposure. In this paper, it is hypothesized that the optimal benefits for light therapy can be achieved by simulating light conditions from natural daylight, on average 12 hours of bright light exposure during the day and 12 hours of no light at night. To validate this theory, a consumer friendly light therapy glasses using an innovative nano coating was engineered to allow for full day unencumbered usage.
The Lumos Glasses' nano-coating design is a state of the art advancement in the light therapy wearable space. LED light sources mounted on the side legs (temples) of the glasses project a band of wavelengths of light centred around 480nm (most impactful for neurobiology based on melanopsin response) onto the nano-coating of the glasses, which is designed to reflect only this specific band of light back into the eyes of the user. This design allows the user to be able to see the world through a regular looking pair of glasses while receiving light therapy. The nano-coating, by design, also filters out 480nm band light from the external environment, thus allowing the glasses to be used as blue light blocking glasses in the evenings when the LEDs are off. Due to the geometry of reflection, the light from the glasses enters at an angle of approximately 35 degrees into the user's eyes. This design is unique in that it is able to miss the fovea region of the eye, allowing for less obstructing of vision, while still activating the ganglion cells which are responsible for photobiology.
Because of the unique light delivery method, it is important that the clinical effect of light therapy through the method of angular light delivery through the nano-coating on glasses is validated. The first objective study is to validate the functional effect of the glasses on depression and sleep improvements through a double blind placebo controlled trial.
In the trial, participants are obligated to wear the glasses for 30 minutes a day, however, are strongly recommended to wear it for longer based on the hypothesis above (up to 12 hours during the day following the natural light dark cycle). It is hypothesized that longer durations of usage (matching the natural cycle) would lead to better results. Thus, the second objective of the study is to observe the distribution of adherence and usage time of the glasses in the study population, as well as determine the correlation between average duration of usage and depression and sleep score improvements.
- Conditions
- Depression, Sleep Disturbance
- Being tested
- Lumos Glasses
- Medical subject headings
- Depression, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumos GlassesDevice
The Lumos Glasses provided tailored blue light therapy and blue light filtering based on the time of day and the user's ambient light conditions. It combines the effect of bright blue light therapy and blue light blocking.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | The treatment group receives fully operational light therapy glasses, with an optimal light output of 500-700 melanopic lux during full power. The users are recommended to wear the glasses for as long as possible during the day, with a minimum requirement of 20 minutes per day. After 8 weeks, this group is cross-overed to receive the placeobo (low dose 50-70 melanopic lux) treatment for another 8 weeks. Receives: Device: Lumos Glasses |
| control group | Placebo comparator | The control group receives placebo operational light therapy glasses, operating at 50-70 melanopic lux during full power. The users are recommended to wear the glasses for as long as possible during the day, with a minimum requirement of 20 minutes per day.
At week 8, the glasses ramp up to the full 500-700 melanopic lux and becomes equivalent to the active comparator group. Receives: Device: Lumos Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (MADRS) Improvements
Improvement of depression rating post intervention
Measured: 8 weeks, assessed by clinical team at week 0, 4 and 8
PROMIS-Sleep Disturbance-Short Form
Improvement of patient reported sleep rating post intervention
Measured: 8 weeks, assessed by clinical team at week 0, 4 and 8, self assessed at week 1, 2 ,3, 5, 6, 7
Secondary outcomes (2)
Reaction Time Test
Reaction time test using the smartphone based Psychomotor Vigilance Task
Measured: 8 weeks, self assessed weekly via the smartphone app at 8pm
Memory test
Paired word test using the smartphone
Measured: 8 weeks, self assessed weekly via the smartphone app at 8pm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start3 Sep 2024
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group receives full dose light therapy for the full 8 weeks. The control group receives placebo light therapy from week 1 to week 4, followed by full dose light therapy from week 4 to week 8
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Lumos Health Inc.
- Responsible party
- Sponsor
- Investigators
- Jonathan M Oakman, Phd, Psychology, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168954
- Sponsor's protocol ID
- 43406
- Status last verified
- Aug 2025
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized participant data will be shared, along with study protocol and statistical analysis methods
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Light Therapy Glasses for Sleep and Mental Wellness, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07168954
- Acronym / sponsor ID
- 43406
- Conditions
- Depression, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Lumos Health Inc.
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 11 Sep 2025 (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.
A pair of smart light therapy glasses (Lumos Glasses) was engineered to control the amount of blue light exposure at a person's eyes through a battery powered light source and nano-coating that reflect blue light.
The research aims to study the effects of this pair of light therapy glasses on depression and sleep.
In addition, the research aims to study the effects of duration of use and its correlation with depression and sleep improvements.
Detailed description
Light has a fundamental impact on human biology. Bright light triggers photoreceptors at the back of the retina to induce neurobiological changes in the brain, affecting neurotransmitter levels such as melatonin and cortisol. For those struggling with depression and sleeping disorders, medical professionals generally recommend the use of a light therapy lamp for 30 minutes a day and the patient begins to improve within the first few weeks of use. However, due to the practical limitations of current light therapy devices such as lamps and head gears, longer durations (2 hours or more) of light therapy each day are often considered infeasible for a modern person, and even adherence to 30 minute are low. As such, the correlation of light therapy duration on sleep and mood improvements are not well understood. Due to this hardware limitation, many research efforts aim to study methods to reduce the duration of light therapy for practical benefits, leading to significant limitations and bias in the understanding of light therapy as well as its clinical implications.
From an alternate perspective of understanding, while the intensity of light from a light therapy box (5000 - 10 000 lux) is brighter than average indoor conditions (500 lux), it rarely exceeds the brightness of light from natural outdoors (up to 100 000 lux). And research also suggests that spending time outdoors could be just as effective as a method as light therapy in treating seasonal affective disorder. As such, it is possible that light therapy's role is to make up for a lack of natural light exposure. In this paper, it is hypothesized that the optimal benefits for light therapy can be achieved by simulating light conditions from natural daylight, on average 12 hours of bright light exposure during the day and 12 hours of no light at night. To validate this theory, a consumer friendly light therapy glasses using an innovative nano coating was engineered to allow for full day unencumbered usage.
The Lumos Glasses' nano-coating design is a state of the art advancement in the light therapy wearable space. LED light sources mounted on the side legs (temples) of the glasses project a band of wavelengths of light centred around 480nm (most impactful for neurobiology based on melanopsin response) onto the nano-coating of the glasses, which is designed to reflect only this specific band of light back into the eyes of the user. This design allows the user to be able to see the world through a regular looking pair of glasses while receiving light therapy. The nano-coating, by design, also filters out 480nm band light from the external environment, thus allowing the glasses to be used as blue light blocking glasses in the evenings when the LEDs are off. Due to the geometry of reflection, the light from the glasses enters at an angle of approximately 35 degrees into the user's eyes. This design is unique in that it is able to miss the fovea region of the eye, allowing for less obstructing of vision, while still activating the ganglion cells which are responsible for photobiology.
Because of the unique light delivery method, it is important that the clinical effect of light therapy through the method of angular light delivery through the nano-coating on glasses is validated. The first objective study is to validate the functional effect of the glasses on depression and sleep improvements through a double blind placebo controlled trial.
In the trial, participants are obligated to wear the glasses for 30 minutes a day, however, are strongly recommended to wear it for longer based on the hypothesis above (up to 12 hours during the day following the natural light dark cycle). It is hypothesized that longer durations of usage (matching the natural cycle) would lead to better results. Thus, the second objective of the study is to observe the distribution of adherence and usage time of the glasses in the study population, as well as determine the correlation between average duration of usage and depression and sleep score improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group receives full dose light therapy for the full 8 weeks. The control group receives placebo light therapy from week 1 to week 4, followed by full dose light therapy from week 4 to week 8
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Device: Lumos GlassesThe treatment group receives fully operational light therapy glasses, with an optimal light output of 500-700 melanopic lux during full power. The users are recommended to wear the glasses for as long as possible during the day, with a minimum requirement of 20 minutes per day. After 8 weeks, this group is cross-overed to receive the placeobo (low dose 50-70 melanopic lux) treatment for another 8 weeks. |
| control group | Placebo comparator | Device: Lumos GlassesThe control group receives placebo operational light therapy glasses, operating at 50-70 melanopic lux during full power. The users are recommended to wear the glasses for as long as possible during the day, with a minimum requirement of 20 minutes per day. At week 8, the glasses ramp up to the full 500-700 melanopic lux and becomes equivalent to the active comparator group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults, any gender, 18+ years old, residing in Ontario Montgomery Asberg Depression Rating Scale Score > 7 or PROMIS score >25 Spend on average less than 2 hours outdoors daily.
Key exclusion criteria (1 listed)
- MADRS Score above 45, or MADRS suicide score is 5 or 6 People with eye disorders or previous eye surgeries. People who have cataracts, macular degeneration, diabetic retinopathy, or other eye disorders. People taking light sensitizing medication. People with bipolar, psychotic disorders or a history of these disorders. People with epilepsy, or history of epilepsy. People with electronic implants, such as pacemakers. Prescription glasses wearers, except for people who can self-supply contact Page 6 of 40 lenses for the duration of the study. People who do not have an iOS or Android based smartphone Shift workers who work night shift or rotating shifts with night shifts
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 |
|---|---|---|
| Lumos GlassesThe Lumos Glasses provided tailored blue light therapy and blue light filtering based on the time of day and the user's ambient light conditions. It combines the effect of bright blue light therapy and blue light blocking. | Device | Treatment group, control group |
Primary outcome
Montgomery Asberg Depression Rating Scale (MADRS) Improvements
Time frame: 8 weeks, assessed by clinical team at week 0, 4 and 8
Improvement of depression rating post intervention
PROMIS-Sleep Disturbance-Short Form
Time frame: 8 weeks, assessed by clinical team at week 0, 4 and 8, self assessed at week 1, 2 ,3, 5, 6, 7
Improvement of patient reported sleep rating post intervention
2 secondary outcomes
Reaction Time Test
Time frame: 8 weeks, self assessed weekly via the smartphone app at 8pm
Memory test
Time frame: 8 weeks, self assessed weekly via the smartphone app at 8pm
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 11 Sep 2025.
- Website of the Lumos Glasses productLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized participant data will be shared, along with study protocol and statistical analysis methods
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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.
Jonathan M Oakman, Phd, Psychology principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumos Glasses in people with Depression and Sleep Disturbance, run by University of Waterloo at 1 site in Canada.
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 1 inclusion and 1 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 11 Sep 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 Canada. 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. 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?
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?
Montgomery Asberg Depression Rating Scale (MADRS) Improvements (time frame: 8 weeks, assessed by clinical team at week 0, 4 and 8). The study lists 2 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 11 Sep 2025.