- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04745312
Effect of Lighting Supplementation on Daytime Cognition
February 16, 2022 updated by: Shadab A Rahman, Brigham and Women's Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- 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 Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
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
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ambient light
Fluorescent ambient lighting
|
Ambient room lighting will be supplemented with additional light from a task lamp.
|
|
Experimental: Ambient light plus task lamp
Fluorescent ambient lighting plus task lamp
|
Ambient room lighting will be supplemented with additional light from a task lamp.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Working memory
Time Frame: 8 hour light exposure
|
Percent correct responses on a 2-minute mental arithmetic task
|
8 hour light exposure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedural learning
Time Frame: 8 hour light exposure
|
Percent change in the number of correct sequences on the Motor Sequence Task
|
8 hour light exposure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vigilance
Time Frame: 8 hour light exposure
|
Reaction time and lapses on the Psychomotor Vigilance Task
|
8 hour light exposure
|
|
Subjective sleepiness
Time Frame: 8 hour light exposure
|
Subjective sleepiness assessed by the Karolinska Sleepiness Scale - Scale from 1-9 where higher scores indicate greater sleepiness
|
8 hour light exposure
|
|
Memory recall
Time Frame: 8 hour light exposure
|
Percentage of correctly recalled words on a paired associates task
|
8 hour light exposure
|
|
Psychological distress
Time Frame: 8 hour light exposure
|
Total score on the Profile of Mood States (POMS)
|
8 hour light exposure
|
|
Affect
Time Frame: 8 hour light exposure
|
Positive and negative affect scores assessed by the PANAS
|
8 hour light exposure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shadab A Rahman, PhD, MPH, Brigham and Women's Hospital
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 (Actual)
March 1, 2021
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
February 4, 2021
First Submitted That Met QC Criteria
February 4, 2021
First Posted (Actual)
February 9, 2021
Study Record Updates
Last Update Posted (Actual)
February 18, 2022
Last Update Submitted That Met QC Criteria
February 16, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2019P000900
- 2020A011565 (Other Grant/Funding Number: Biological Innovation and Optimization Systems, LLC.)
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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