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
About this trial
This is an interventional basic science trial for Postural Balance
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)
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
NCT ID
NCT01712243
First Posted
October 19, 2012
Last Updated
November 1, 2016
Sponsor
VA Palo Alto Health Care System
Collaborators
Stanford University
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
Learn more about this trial
Light to Maximize Vision, Minimize Insomnia
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