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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
  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

Further study details as provided by VA Office of Research and Development:

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: June 2017
Estimated Primary Completion Date: January 2017 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350505

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Jamie M Zeitzer, PhD VA Palo Alto Health Care System, Palo Alto, CA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01350505     History of Changes
Other Study ID Numbers: E0773-P 
Study First Received: May 6, 2011
Last Updated: October 27, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: 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.

Keywords provided by VA Office of Research and Development:
Postural Balance
Sleep Initiation and Maintenance Disorders

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

ClinicalTrials.gov processed this record on December 02, 2016