Effect of Lighting Supplementation on Daytime Cognition

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04745312
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-visual Effects of Light	Device: Visible light	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized crossoverRandomized crossover
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Effect of Lighting Supplementation on Cognitive Task Performance During the Day
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ambient light Fluorescent ambient lighting	Device: Visible light; 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	Device: Visible light; Ambient room lighting will be supplemented with additional light from a task lamp.

Outcome Measures

Primary Outcome Measures

1. Working memory [8 hour light exposure]

   Percent correct responses on a 2-minute mental arithmetic task

Secondary Outcome Measures

1. Procedural learning [8 hour light exposure]

   Percent change in the number of correct sequences on the Motor Sequence Task

Other Outcome Measures

1. Vigilance [8 hour light exposure]

   Reaction time and lapses on the Psychomotor Vigilance Task

2. Subjective sleepiness [8 hour light exposure]

   Subjective sleepiness assessed by the Karolinska Sleepiness Scale - Scale from 1-9 where higher scores indicate greater sleepiness

3. Memory recall [8 hour light exposure]

   Percentage of correctly recalled words on a paired associates task

4. Psychological distress [8 hour light exposure]

   Total score on the Profile of Mood States (POMS)

5. Affect [8 hour light exposure]

   Positive and negative affect scores assessed by the PANAS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Shadab A Rahman, PhD, MPH, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shadab A Rahman, Associate Neuroscientist, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT04745312
• Other Study ID Numbers: 2019P000900; 2020A011565
• First Posted: Feb 9, 2021
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shadab A Rahman, Associate Neuroscientist, Brigham and Women's Hospital: Light; Cognition; Alertness; Learning

Study Results

No Results Posted as of Feb 18, 2022