NCT01712243

Brief Summary

The purpose of this study is to determine whether specific wavelengths of light at night can be used to improve mobile balance while simultaneously not increasing alertness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration 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

First Submitted

Initial submission to the registry

October 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

October 19, 2012

Last Update Submit

November 1, 2016

Conditions

Postural Balance

Outcome Measures

Primary Outcomes (2)

  • Mobile balance

    Mobile balance as determined using a GaitRite walkway

    15 minutes

  • Alertness

    Alertness as determined by electroencephalographic power density

    15 minutes

Study Arms (3)

Dim light

ACTIVE COMPARATOR

15 minutes of very dim (\<1 lux) light during the night

Other: Light

Room light

ACTIVE COMPARATOR

15 minutes of normal room light (\~100 lux) during the night

Other: Light

Colored light

EXPERIMENTAL

15 minutes of colored light during the night

Other: Light

Interventions

LightOTHER
Colored lightDim lightRoom light

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 55-85
  • At least 20/200 corrected visual acuity
  • Greater than 20° visual field with no lower visual field loss
  • Stable health
  • Male or female
  • Normal color vision
  • Normal hearing

You may not qualify if:

  • Extreme chronotype
  • Sleep disorders
  • Dementia
  • Smoker
  • Depression
  • Alcohol abuse
  • Use of illegal drugs
  • Use of sleep/wake altering drugs on an acute or as needed basis (including nutraceuticals, antihistamines)
  • Use of light sensitizing drugs
  • Self-reported history of nocturia (\>3 times per night)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 19, 2012

First Posted

October 23, 2012

Study Start

December 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)