Non-visual Effects of LightNCT07471126
Sleep, Light, Circadian, Central Oxidative Stress
A study testing Chronic Variable Sleep Deficiency, Sleep- and Circadian-Informed Lighting and Dim Light in people with Non-visual Effects of Light and Chronic Variable Sleep Deficiency, run by Beth Israel Deaconess Medical Center.
Trial summary
Irregular sleep timing and sleep deficiency are pervasive in society despite evidence that sleep deficiency impairs cognition and is linked to neurodegenerative disease. Potential pathways underlying the adverse cognitive function and brain health associated with irregular insufficient sleep include misalignment of… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-visual Effects of Light, Chronic Variable Sleep Deficiency
- What is being tested?
- Chronic Variable Sleep Deficiency, Sleep- and Circadian-Informed Lighting and Dim Light
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Jun 2029
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants 18-40 years old.
Who cannot join
- Volunteers must be drug-free (including caffeine, nicotine, and alcohol) for the entire duration of the study, with no history of drug or alcohol dependency.
- Subjects must be free from any significant impairments of the visual system, including color blindness.
- Subjects must be ambulatory, have no major visual or auditory handicaps, and be free from any major acute, chronic or debilitating medical conditions.
- history of psychiatric illnesses or psychiatric disorders
- History of consistent work during the overnight hours for the one year prior to study.
- History of transmeridian travel >2 times zones, will require a 1 week wash out per hour of time difference from the Eastern Standard/Daylight Time zone.
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: Role of Ambien Lighting in Circadian Misalignment in a Chronic Variable Sleep Deficiency Paradigm: Impact on Sleep, Cognition, and Central Oxidative Stress
Irregular sleep timing and sleep deficiency are pervasive in society despite evidence that sleep deficiency impairs cognition and is linked to neurodegenerative disease. Potential pathways underlying the adverse cognitive function and brain health associated with irregular insufficient sleep include misalignment of sleep from the internal ~24-hour body clock and brain oxidative stress. This research will investigate these putative pathways and inform future interventions to mitigate the impact of sleep loss on cognition and brain health.
Read the detailed description
Millions of adults in the US vary their day-to-day sleep timing to accommodate social and work demands. These irregular sleep schedules promote poor and insufficient sleep. Chronic insufficient sleep increases the risk of errors, accidents and developing various health disorders including neurodegenerative disease. The underlying mechanistic pathways by which irregular sleep schedules promote cognitive impairment and neurodegenerative disease remains poorly understood, and the proposed work will address this critical knowledge gap. Our preliminary data indicate that irregular sleep schedules induce circadian misalignment which we hypothesize is caused by irregular patterns of light exposure. Supporting this hypothesis, our pilot data show that implementing sleep- and circadian-informed lighting (SCIL) attenuated circadian misalignment and improved cognitive function, even in the presence of irregular sleep timing. Additionally, our pilot studies show that more sleep disturbance correlated with more oxidative stress (OS) in brain regions that are associated with cognitive function in humans, and consequently more OS in these regions correlated with poorer cognitive performance. Taken together, our results suggest that circadian misalignment and OS associated with insufficient sleep may be in the causal pathway for cognitive impairment due to irregular sleep schedules and SCIL may be a potential countermeasure. Therefore, the objective of this project is to determine the impact of chronic variable sleep deficiency (CVSD), as a model of irregular sleep schedules, on circadian misalignment, OS and cognition. Additionally, we will explore the role of ambient light exposure and the impact of SCIL conditions in a CVSD paradigm (2 cycles of two consecutive nights of 3 h of sleep followed by one 8-h recovery sleep) on neurophysiologic and neurocognitive outcomes. In a 7-night inpatient study, young healthy adults will be randomized to one of four conditions: dim-light control (8 h sleep each night), dim-light CVSD, room-light CVSD, and SCIL CVSD. The primary outcomes include circadian phase resetting, OS via central glutathione measured by magnetic resonance spectroscopy, and cognitive performance. The aims of the study are to: (1) Determine the causal role of light exposure in circadian phase resetting in CVSD, (2) evaluate the impact of SCIL in CVSD on circadian phase resetting, sleep and cognition, (3) evaluate the impact of sleep deficiency and circadian phase resetting in CVSD on OS, and (4) evaluate the association between cognition and central OS in CVSD. Our work will be a comprehensive evaluation of two mechanistic pathways - circadian misalignment and OS -that can contribute to cognitive impairment associated with irregular sleep schedules. We expect our experimental and analytic paradigm to be a foundational resource that can be extended to future studies examining mechanisms of cognitive impairment and neurodegenerative diseases associated with sleep loss and irregular sleep schedules, and have a positive public health impact by guiding therapeutic strategies for patients with sleep disorders and the general population at large who experience chronic variable sleep deficiency.
- Being tested
- Chronic Variable Sleep Deficiency, Sleep- and Circadian-Informed Lighting, Dim Light, Room light, Control sleep
- Keywords
- Sleep, Circadian, Light exposure, Oxidative Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Variable Sleep DeficiencyBehavioural
Repeated cycles of sleep restriction followed by recovery sleep.
Sleep- and Circadian-Informed LightingBehavioural
Ambient visible light exposure with modulated intensity and spectrum
Dim LightBehavioural
<3 lux dim ambient lighting while awake
Room lightBehavioural
~90 lux ambient lighting while awake
Control sleepBehavioural
Nightly 8-h sleep opportunity
| Study group | Role | What they receive |
|---|---|---|
| Dim light control | Experimental | Not described Receives: Behavioral: Dim Light; Behavioral: Control sleep |
| Dim-light CVSD | Experimental | Not described Receives: Behavioral: Chronic Variable Sleep Deficiency; Behavioral: Dim Light |
| Room-light CVSD | Experimental | Not described Receives: Behavioral: Chronic Variable Sleep Deficiency; Behavioral: Room light |
| SCIL CVSD | Experimental | Not described Receives: Behavioral: Chronic Variable Sleep Deficiency; Behavioral: Sleep- and Circadian-Informed Lighting |
What is being measured
The primary outcome is the main question the study is designed to answer.
circadian phase shifts in melatonin sulfate rhythm
Measured: Baseline: Day 1 of study, Final: Day 8 of study
Accuracy on the matrix reasoning task
Measured: Daily over 8 days throughout study intervention
WASO on the PSG
Measured: Baseline sleep, first short sleep, second short sleep.
MRS-derived GSH in the mPFC
Measured: Baseline: Day 1 of study, Final: Day 8 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-visual Effects of LightStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shadab Rahman, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471126
- Sponsor's protocol ID
- 2025-P-001806
- Status last verified
- May 2026
- First submitted
- 3 Mar 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ambien Lighting in Circadian Misalignment in a Chronic Variable Sleep Deficiency Paradigm: Impact on Sleep, Cognition, and Central Oxidative Stress
- ClinicalTrials.gov ID
- NCT07471126
- Acronym / sponsor ID
- 2025-P-001806
- Keywords
- Sleep, Circadian, Light exposure, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 13 Mar 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.
Irregular sleep timing and sleep deficiency are pervasive in society despite evidence that sleep deficiency impairs cognition and is linked to neurodegenerative disease. Potential pathways underlying the adverse cognitive function and brain health associated with irregular insufficient sleep include misalignment of sleep from the internal ~24-hour body clock and brain oxidative stress. This research will investigate these putative pathways and inform future interventions to mitigate the impact of sleep loss on cognition and brain health.
Detailed description
Millions of adults in the US vary their day-to-day sleep timing to accommodate social and work demands. These irregular sleep schedules promote poor and insufficient sleep. Chronic insufficient sleep increases the risk of errors, accidents and developing various health disorders including neurodegenerative disease. The underlying mechanistic pathways by which irregular sleep schedules promote cognitive impairment and neurodegenerative disease remains poorly understood, and the proposed work will address this critical knowledge gap. Our preliminary data indicate that irregular sleep schedules induce circadian misalignment which we hypothesize is caused by irregular patterns of light exposure. Supporting this hypothesis, our pilot data show that implementing sleep- and circadian-informed lighting (SCIL) attenuated circadian misalignment and improved cognitive function, even in the presence of irregular sleep timing. Additionally, our pilot studies show that more sleep disturbance correlated with more oxidative stress (OS) in brain regions that are associated with cognitive function in humans, and consequently more OS in these regions correlated with poorer cognitive performance. Taken together, our results suggest that circadian misalignment and OS associated with insufficient sleep may be in the causal pathway for cognitive impairment due to irregular sleep schedules and SCIL may be a potential countermeasure. Therefore, the objective of this project is to determine the impact of chronic variable sleep deficiency (CVSD), as a model of irregular sleep schedules, on circadian misalignment, OS and cognition. Additionally, we will explore the role of ambient light exposure and the impact of SCIL conditions in a CVSD paradigm (2 cycles of two consecutive nights of 3 h of sleep followed by one 8-h recovery sleep) on neurophysiologic and neurocognitive outcomes. In a 7-night inpatient study, young healthy adults will be randomized to one of four conditions: dim-light control (8 h sleep each night), dim-light CVSD, room-light CVSD, and SCIL CVSD. The primary outcomes include circadian phase resetting, OS via central glutathione measured by magnetic resonance spectroscopy, and cognitive performance. The aims of the study are to: (1) Determine the causal role of light exposure in circadian phase resetting in CVSD, (2) evaluate the impact of SCIL in CVSD on circadian phase resetting, sleep and cognition, (3) evaluate the impact of sleep deficiency and circadian phase resetting in CVSD on OS, and (4) evaluate the association between cognition and central OS in CVSD. Our work will be a comprehensive evaluation of two mechanistic pathways - circadian misalignment and OS -that can contribute to cognitive impairment associated with irregular sleep schedules. We expect our experimental and analytic paradigm to be a foundational resource that can be extended to future studies examining mechanisms of cognitive impairment and neurodegenerative diseases associated with sleep loss and irregular sleep schedules, and have a positive public health impact by guiding therapeutic strategies for patients with sleep disorders and the general population at large who experience chronic variable sleep deficiency.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dim light control | Experimental | Behavioral: Dim Light, Behavioral: Control sleep |
| Dim-light CVSD | Experimental | Behavioral: Chronic Variable Sleep Deficiency, Behavioral: Dim Light |
| Room-light CVSD | Experimental | Behavioral: Chronic Variable Sleep Deficiency, Behavioral: Room light |
| SCIL CVSD | Experimental | Behavioral: Chronic Variable Sleep Deficiency, Behavioral: Sleep- and Circadian-Informed Lighting |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy participants 18-40 years old.
Key exclusion criteria (6 listed)
- Volunteers must be drug-free (including caffeine, nicotine, and alcohol) for the entire duration of the study, with no history of drug or alcohol dependency.
- Subjects must be free from any significant impairments of the visual system, including color blindness.
- Subjects must be ambulatory, have no major visual or auditory handicaps, and be free from any major acute, chronic or debilitating medical conditions.
- history of psychiatric illnesses or psychiatric disorders
- History of consistent work during the overnight hours for the one year prior to study.
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 |
|---|---|---|
| Chronic Variable Sleep DeficiencyRepeated cycles of sleep restriction followed by recovery sleep. | Behavioural | Dim-light CVSD, Room-light CVSD, SCIL CVSD |
| Sleep- and Circadian-Informed LightingAmbient visible light exposure with modulated intensity and spectrum | Behavioural | SCIL CVSD |
| Dim Light<3 lux dim ambient lighting while awake | Behavioural | Dim light control, Dim-light CVSD |
| Room light~90 lux ambient lighting while awake | Behavioural | Room-light CVSD |
| Control sleepNightly 8-h sleep opportunity | Behavioural | Dim light control |
Primary outcome
circadian phase shifts in melatonin sulfate rhythm
Time frame: Baseline: Day 1 of study, Final: Day 8 of study
Accuracy on the matrix reasoning task
Time frame: Daily over 8 days throughout study intervention
WASO on the PSG
Time frame: Baseline sleep, first short sleep, second short sleep.
MRS-derived GSH in the mPFC
Time frame: Baseline: Day 1 of study, Final: Day 8 of study
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 11 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Non-visual Effects of Light
Recruiting
Photomotor Reflex to Evaluate the Role of the Non-visual Effects of Light in Neurological, Psychiatric and Ophthalmological Pathologies
Sleep Disorders, Neurological Pathologies
Not yet recruiting
Examining Lithium's Mechanism in Bipolar Disorder
Healthy, Bipolar
Active, not recruiting
Effects of Blue of Glasses VS Standard Lenses on Contrast Sensitivity & Visual Fatigue in Myopic & Non-Myopic Adults
Myopia
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 Chronic Variable Sleep Deficiency, Sleep- and Circadian-Informed Lighting and Dim Light in people with Non-visual Effects of Light and Chronic Variable Sleep Deficiency, run by Beth Israel Deaconess Medical Center.
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 6 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 11 Jun 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. 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 Shadab A Rahman, PhD (617-525-8830, srahman@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circadian phase shifts in melatonin sulfate rhythm (time frame: Baseline: Day 1 of study, Final: Day 8 of study). 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?
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 Jun 2026.