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Trial record 11 of 73 for:    Open Studies | "Sleep Initiation and Maintenance Disorders"
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Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia

This study is not yet open for participant recruitment.
Verified April 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: April 10, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Insomnia
U.S. FDA Resources

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: August 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
Department of Veterans Affairs
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: April 10, 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 May 16, 2013