Dose-dependent Impact of Daytime Lighting on Evening Responses to Light
March 2, 2022 updated by: Jamie M. Zeitzer, Ph.D., Palo Alto Veterans Institute for Research
The purpose of this study is to systematically examine the impact of different intensities of daytime light and the subsequent impact that such exposure has on non-image forming responses to light in the evening.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
48
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 Contact
- Name: Jamie Zeitzer, PhD
- Phone Number: 6504935000
- Email: jzeitzer@stanford.edu
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- VA Palo Alto Health Care System
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18-65
- Good health
- Male or female
- Normal color vision
Exclusion Criteria:
- Sleep disorders
- Extreme chronotypes
- Routine smoker
- Significant hearing loss
- Depressed
- Alcohol use disorder
- Use of illegal drugs
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low room
Low intensity (80 lux) room light
|
10 hours of light exposure during the daytime, starting 2 hours after habitual wake time
|
|
Experimental: Normal room
Normal intensity (150 lux) room light
|
10 hours of light exposure during the daytime, starting 2 hours after habitual wake time
|
|
Experimental: Bright room
High intensity (500 lux) room light
|
10 hours of light exposure during the daytime, starting 2 hours after habitual wake time
|
|
Experimental: Bright
Very high intensity (1000 lux) room light
|
10 hours of light exposure during the daytime, starting 2 hours after habitual wake time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suppression of melatonin production
Time Frame: 4 hours
|
Difference in salivary melatonin concentrations between active arm and 3 lux control condition
|
4 hours
|
|
Phase shift in the timing of melatonin onset
Time Frame: 2 days
|
Change in the onset of melatonin secretion after experimental stimulus
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
July 1, 2022
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
May 7, 2021
First Submitted That Met QC Criteria
May 7, 2021
First Posted (Actual)
May 11, 2021
Study Record Updates
Last Update Posted (Actual)
March 17, 2022
Last Update Submitted That Met QC Criteria
March 2, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Reverse DRC
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.