Non-visual Effects of LightNCT04745312
Effect of Lighting Supplementation on Daytime Cognition
A study testing Visible light in people with Non-visual Effects of Light, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of the study is to examine the efficacy of supplementing sub-optimal ambient room lighting with a task lamp on working memory and procedural learning. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-visual Effects of Light
- What is being tested?
- Visible light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Mar 2022
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-30 years;
- Healthy (no medical, psychiatric or sleep disorders;
- Non-smoking for at least 6 months;
- Body Mass Index of >18 or <30 kg/m2;
- Able to maintain 7-hour consistent sleep schedule during the study
- Able to refrain from caffeine, alcohol, medication and supplements during the study
Who cannot join
- History of alcohol or substance abuse;
- positive result on drugs of abuse urine toxicology;
- Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, narcolepsy, insomnia, or any significant sleep complaint
- Psychiatric disorder, or first degree relative with a psychiatric disorder
- Recent acute or chronic medical disorder
- Use of drugs or medication (birth control OK) likely to affect sleep, alertness or light sensitivity, as determined by the investigators
Show all 11Show fewer
- Visual disorder, including but not limited to color blindness, or family history of glaucoma
- Pregnancy or lactation
- Shift work (> 2 nights / week in the last 3 months and not during the study)
- Transmeridian travel (2 or more time zones) in the past 3 months
- Any other reason as determine by the Principal Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: The Effect of Lighting Supplementation on Cognitive Task Performance During the Day
The aim of the study is to examine the efficacy of supplementing sub-optimal ambient room lighting with a task lamp on working memory and procedural learning.
- Conditions
- Non-visual Effects of Light
- Being tested
- Visible light
- Keywords
- Light, Cognition, Alertness, Learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visible lightDevice
Ambient room lighting will be supplemented with additional light from a task lamp.
| Study group | Role | What they receive |
|---|---|---|
| Ambient light | Active comparator | Fluorescent ambient lighting Receives: Device: Visible light |
| Ambient light plus task lamp | Experimental | Fluorescent ambient lighting plus task lamp Receives: Device: Visible light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory
Percent correct responses on a 2-minute mental arithmetic task
Measured: 8 hour light exposure
Secondary outcomes (1)
Procedural learning
Percent change in the number of correct sequences on the Motor Sequence Task
Measured: 8 hour light exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
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 Non-visual Effects of LightStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shadab A Rahman, Brigham and Women's Hospital
- Investigators
- Shadab A Rahman, PhD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745312
- Sponsor's protocol ID
- 2019P000900
- Other IDs
- 2020A011565
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grant LK, Crosthwaite PC, Mayer MD, Wang W, Stickgold R, St Hilaire MA, Lockley SW, Rahman SA. Supplementation of ambient lighting with a task lamp improves daytime alertness and cognitive performance in sleep-restricted individuals. Sleep. 2023 Aug 14;46(8):zsad096. doi: 10.1093/sleep/zsad096.
PubMed 37026184
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lighting Supplementation on Cognitive Task Performance During the Day
- ClinicalTrials.gov ID
- NCT04745312
- Acronym / sponsor ID
- 2019P000900
- Conditions
- Non-visual Effects of Light
- Keywords
- Light, Cognition, Alertness, Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 9 Feb 2021 (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 aim of the study is to examine the efficacy of supplementing sub-optimal ambient room lighting with a task lamp on working memory and procedural learning.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover
| Arm | Type | Receives |
|---|---|---|
| Ambient light | Active comparator | Device: Visible lightFluorescent ambient lighting |
| Ambient light plus task lamp | Experimental | Device: Visible lightFluorescent ambient lighting plus task lamp |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18-30 years;
- Healthy (no medical, psychiatric or sleep disorders;
- Non-smoking for at least 6 months;
- Body Mass Index of >18 or <30 kg/m2;
- Able to maintain 7-hour consistent sleep schedule during the study
Key exclusion criteria (11 listed)
- History of alcohol or substance abuse;
- positive result on drugs of abuse urine toxicology;
- Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, narcolepsy, insomnia, or any significant sleep complaint
- Psychiatric disorder, or first degree relative with a psychiatric disorder
- Recent acute or chronic medical disorder
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 |
|---|---|---|
| Visible lightAmbient room lighting will be supplemented with additional light from a task lamp. | Device | Ambient light, Ambient light plus task lamp |
Primary outcome
Working memory
Time frame: 8 hour light exposure
Percent correct responses on a 2-minute mental arithmetic task
1 secondary outcome
Procedural learning
Time frame: 8 hour light exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Derived from this study: PubMed 37026184Grant LK, Crosthwaite PC, Mayer MD, Wang W, Stickgold R, St Hilaire MA, Lockley SW, Rahman SA. Supplementation of ambient lighting with a task lamp improves daytime alertness and cognitive performance in sleep-restricted individuals. Sleep. 2023 Aug 14;46(8):zsad096. doi: 10.1093/sleep/zsad096.
- Individual participant dataSharing planned: No
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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.
Shadab A Rahman, PhD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visible light in people with Non-visual Effects of Light, run by Brigham and Women's Hospital at 1 site in United States.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Feb 2022. 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 United States. 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?
Results are not available in the source record.
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?
Working memory (time frame: 8 hour light exposure). 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 NCT04745312, 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 18 Feb 2022.