Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia

This study is not yet open for participant recruitment.
Verified October 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01350505
First received: May 6, 2011
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.


Condition Intervention
Falls
Balance
Insomnia
Aging
Behavioral: Light exposure

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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in balance [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Change in balance after 30 minutes of nocturnal light exposure


Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
White room light
Behavioral: Light exposure
30 minutes of experimental light exposure during the night
Placebo Comparator: Arm 2
Dim white light
Behavioral: Light exposure
30 minutes of experimental light exposure during the night
Experimental: Arm 3
Red light
Behavioral: Light exposure
30 minutes of experimental light exposure during the night
Experimental: Arm 4
Orange light
Behavioral: Light exposure
30 minutes of experimental light exposure during the night
Experimental: Arm 5
Yellow light
Behavioral: Light exposure
30 minutes of experimental light exposure during the night

  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
  • Stable health
  • Normal color vision

Exclusion Criteria:

  • Alcohol abuse
  • Depression
  • Sleep disorders
  • Smoking
  • Use of illegal drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350505

Contacts
Contact: Jamie M Zeitzer, PhD (650) 493-5000 ext 62410 jamie.zeitzer@va.gov

Locations
United States, California
VA Palo Alto Health Care System Not yet recruiting
Palo Alto, California, United States, 94304-1290
Contact: Jamie M Zeitzer, PhD    650-493-5000 ext 62410    jamie.zeitzer@va.gov   
Principal Investigator: Jamie M. Zeitzer, PhD         
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30329
Contact: Theodore M Johnson, MD       tmjohns@emory.edu   
Sponsors and Collaborators
Investigators
Principal Investigator: Jamie M. Zeitzer, PhD VA Palo Alto Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01350505     History of Changes
Other Study ID Numbers: E0773-P
Study First Received: May 6, 2011
Last Updated: October 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Postural Balance
Sleep Initiation and Maintenance Disorders

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014