NCT02936674

Brief Summary

The purpose of this study is to examine the effects of complex, broad-band spectra light on the production of melatonin in humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

8 months

First QC Date

October 7, 2016

Last Update Submit

January 3, 2018

Conditions

Melatonin

Outcome Measures

Primary Outcomes (1)

  • Melatonin suppression

    The amount of declination of salivary melatonin concentrations between the start of the light and the end of the light (4 hours later) will be compared between the conditions.

    4 Hours

Study Arms (2)

Light 1

EXPERIMENTAL

Light 1 will have an altered color composition as compared with a standard LED bulb.

Device: Light - alternate

Light 2

ACTIVE COMPARATOR

Light 2 will be a standard LED bulb.

Device: Light - standard

Interventions

Light - standardDEVICE

Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with standard spectral distribution

Light 2
Light - alternateDEVICE

Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with an altered spectral distribution (different color)

Light 1

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Stable health
  • Normal color vision
  • Normal hearing
  • years old

You may not qualify if:

  • Significant depressive symptoms
  • Pregnant or nursing
  • Ocular pathologies
  • Unstable or severe medical or psychiatric condition
  • Extreme morning/evening type
  • Regular smoker
  • Use of medications that impact ocular function
  • Alcohol use disorder
  • Use of illegal drugs
  • Irregular use of antihistamines, antidepressants, or sleeping medications

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 18, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

January 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

All relevant individual data will be published.

Locations

US(1)