Sleep, Light, Circadian, Central Oxidative Stress

June 9, 2026 updated by: Shadab Rahman, Beth Israel Deaconess Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy participants 18-40 years old.

Exclusion Criteria:

  1. 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.
  2. Subjects must be free from any significant impairments of the visual system, including color blindness.
  3. Subjects must be ambulatory, have no major visual or auditory handicaps, and be free from any major acute, chronic or debilitating medical conditions.
  4. history of psychiatric illnesses or psychiatric disorders
  5. History of consistent work during the overnight hours for the one year prior to study.
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dim light control
Behavioral: Dim Light
<3 lux dim ambient lighting while awake
Behavioral: Control sleep
Nightly 8-h sleep opportunity
Experimental: Dim-light CVSD
Behavioral: Dim Light
<3 lux dim ambient lighting while awake
Behavioral: Chronic Variable Sleep Deficiency
Repeated cycles of sleep restriction followed by recovery sleep.
Experimental: Room-light CVSD
Behavioral: Chronic Variable Sleep Deficiency
Repeated cycles of sleep restriction followed by recovery sleep.
Behavioral: Room light
~90 lux ambient lighting while awake
Experimental: SCIL CVSD
Behavioral: Chronic Variable Sleep Deficiency
Repeated cycles of sleep restriction followed by recovery sleep.
Behavioral: Sleep- and Circadian-Informed Lighting
Ambient visible light exposure with modulated intensity and spectrum

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
circadian phase shifts in melatonin sulfate rhythm
Time Frame: Baseline: Day 1 of study, Final: Day 8 of study
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
Daily over 8 days throughout study intervention
WASO on the PSG
Time Frame: Baseline sleep, first short sleep, second short sleep.
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
Baseline: Day 1 of study, Final: Day 8 of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-P-001806

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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