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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01350505
First received: May 6, 2011
Last updated: October 27, 2016
Last verified: October 2016

May 6, 2011
October 27, 2016
October 2013
January 2017   (final data collection date for primary outcome measure)
Change in balance [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Change in balance after 30 minutes of nocturnal light exposure
Same as current
Complete list of historical versions of study NCT01350505 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia
Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia
To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Falls
  • Balance
  • Insomnia
  • Aging
Behavioral: Light exposure
30 minutes of experimental light exposure during the night
  • Active Comparator: Arm 1
    White room light
    Intervention: Behavioral: Light exposure
  • Placebo Comparator: Arm 2
    Dim white light
    Intervention: Behavioral: Light exposure
  • Experimental: Arm 3
    Red light
    Intervention: Behavioral: Light exposure
  • Experimental: Arm 4
    Orange light
    Intervention: Behavioral: Light exposure
  • Experimental: Arm 5
    Yellow light
    Intervention: Behavioral: Light exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
June 2017
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 55-85
  • Stable health
  • Normal color vision

Exclusion Criteria:

  • Alcohol abuse
  • Depression
  • Sleep disorders
  • Smoking
  • Use of illegal drugs
Both
55 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01350505
E0773-P
No
Yes
All relevant summary data is presented in a publication under review. Anonymized, individual participant data would be made available upon request and completion of necessary documentation.
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Jamie M Zeitzer, PhD VA Palo Alto Health Care System, Palo Alto, CA
VA Office of Research and Development
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP