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Light to Maximize Vision, Minimize Insomnia

Primary Purpose

Postural Balance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postural Balance

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Dim light

Room light

Colored light

Arm Description

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

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

15 minutes of colored light during the night

Outcomes

Primary Outcome Measures

Mobile balance
Mobile balance as determined using a GaitRite walkway
Alertness
Alertness as determined by electroencephalographic power density

Secondary Outcome Measures

Full Information

First Posted
October 19, 2012
Last Updated
November 1, 2016
Sponsor
VA Palo Alto Health Care System
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT01712243
Brief Title
Light to Maximize Vision, Minimize Insomnia
Official Title
Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
Collaborators
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Balance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dim light
Arm Type
Active Comparator
Arm Description
15 minutes of very dim (<1 lux) light during the night
Arm Title
Room light
Arm Type
Active Comparator
Arm Description
15 minutes of normal room light (~100 lux) during the night
Arm Title
Colored light
Arm Type
Experimental
Arm Description
15 minutes of colored light during the night
Intervention Type
Other
Intervention Name(s)
Light
Primary Outcome Measure Information:
Title
Mobile balance
Description
Mobile balance as determined using a GaitRite walkway
Time Frame
15 minutes
Title
Alertness
Description
Alertness as determined by electroencephalographic power density
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

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Light to Maximize Vision, Minimize Insomnia

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