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

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ClinicalTrials.gov Identifier: NCT01350505
Recruitment Status : Active, not recruiting
First Posted : May 9, 2011
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.

Condition or disease Intervention/treatment
Falls Balance Insomnia Aging Behavioral: Light exposure

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia
Actual Study Start Date : October 15, 2013
Primary Completion Date : January 31, 2017
Estimated Study Completion Date : June 2017
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change in balance [ Time Frame: 30 minutes ]
    Change in balance after 30 minutes of nocturnal light exposure


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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