NCT04882280

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

May 7, 2021

Last Update Submit

March 2, 2022

Conditions

Sleep

Outcome Measures

Primary Outcomes (2)

  • Suppression of melatonin production

    Difference in salivary melatonin concentrations between active arm and 3 lux control condition

    4 hours

  • Phase shift in the timing of melatonin onset

    Change in the onset of melatonin secretion after experimental stimulus

    2 days

Study Arms (4)

Low room

EXPERIMENTAL

Low intensity (80 lux) room light

Behavioral: Light

Normal room

EXPERIMENTAL

Normal intensity (150 lux) room light

Behavioral: Light

Bright room

EXPERIMENTAL

High intensity (500 lux) room light

Behavioral: Light

Bright

EXPERIMENTAL

Very high intensity (1000 lux) room light

Behavioral: Light

Interventions

LightBEHAVIORAL

10 hours of light exposure during the daytime, starting 2 hours after habitual wake time

BrightBright roomLow roomNormal room

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-65
  • Good health
  • Male or female
  • Normal color vision

You may not qualify if:

  • Sleep disorders
  • Extreme chronotypes
  • Routine smoker
  • Significant hearing loss
  • Depressed
  • Alcohol use disorder
  • Use of illegal drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Light

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

Central Study Contacts

Jamie Zeitzer, PhD

CONTACT

6504935000jzeitzer@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 11, 2021

Study Start

July 1, 2022

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)