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Light to Maximize Vision, Minimize Insomnia

This study is not yet open for participant recruitment.
Verified October 2012 by VA Palo Alto Health Care System
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT01712243
First received: October 19, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Postural Balance
 Other: Light

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia

Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Mobile balance [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Mobile balance as determined using a GaitRite walkway

  • Alertness [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Alertness as determined by electroencephalographic power density


Estimated Enrollment: 27
Study Start Date: July 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dim light
15 minutes of very dim (<1 lux) light during the night
 Other: Light
Active Comparator: Room light
15 minutes of normal room light (~100 lux) during the night
 Other: Light
Experimental: Colored light
15 minutes of colored light during the night
 Other: Light

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712243

Contacts
Contact: Jamie M Zeitzer, PhD 650-493-5000 ext 62410 jzeitzer@stanford.edu

Locations
United States, California
VA Palo Alto Health Care System Not yet recruiting
Palo Alto, California, United States, 94304
Principal Investigator: Jamie M Zeitzer, PhD            
Sponsors and Collaborators
VA Palo Alto Health Care System
Stanford University
  More Information

No publications provided

Responsible Party: Jamie M. Zeitzer, Ph.D., Assistant Professor, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01712243     History of Changes
Other Study ID Numbers: 1I21RX000773-01A2
Study First Received: October 19, 2012
Last Updated: October 19, 2012
Health Authority: United States: Federal Government
United States: Department of Veterans Affairs

ClinicalTrials.gov processed this record on May 23, 2013