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

Primary Purpose

Falls, Balance, Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
White light exposure
Dim white light exposure
Very dim white light exposure
Dim orange light exposure
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Falls focused on measuring Postural Balance, Sleep Initiation and Maintenance Disorders

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Alcohol abuse
  • Depression
  • Sleep disorders
  • Smoking
  • Use of illegal drugs

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

13 minutes of light at night (2 hours after bedtime)

Outcomes

Primary Outcome Measures

Change in Balance
Balance was assessed during a 13-minute nocturnal light exposure (4 different conditions) and differences between the conditions were assessed. To determine goodness of balance while walking, the variability in stride length (i.e., variance in stride-to-stride length) was calculated in each of the conditions. Increased variability in stride length is associated with increased risk of falling.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2011
Last Updated
September 26, 2018
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01350505
Brief Title
Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia
Official Title
Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 15, 2013 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Falls, Balance, Insomnia, Aging
Keywords
Postural Balance, Sleep Initiation and Maintenance Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The order of the interventions were randomized to the four visits.
Masking
ParticipantInvestigator
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Experimental
Arm Description
13 minutes of light at night (2 hours after bedtime)
Intervention Type
Behavioral
Intervention Name(s)
White light exposure
Intervention Description
~200 lux of broad spectrum white light
Intervention Type
Behavioral
Intervention Name(s)
Dim white light exposure
Intervention Description
~28 lux of broad spectrum white light
Intervention Type
Behavioral
Intervention Name(s)
Very dim white light exposure
Intervention Description
<0.5 lux of broad spectrum white light
Intervention Type
Behavioral
Intervention Name(s)
Dim orange light exposure
Intervention Description
~28 lux of orange light
Primary Outcome Measure Information:
Title
Change in Balance
Description
Balance was assessed during a 13-minute nocturnal light exposure (4 different conditions) and differences between the conditions were assessed. To determine goodness of balance while walking, the variability in stride length (i.e., variance in stride-to-stride length) was calculated in each of the conditions. Increased variability in stride length is associated with increased risk of falling.
Time Frame
13 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 55-85 Stable health Normal color vision Exclusion Criteria: Alcohol abuse Depression Sleep disorders Smoking Use of illegal drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie M Zeitzer, PhD
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
27448415
Citation
McBean AL, Najjar RP, Schuchard RA, Hall CD, Wang CA, Ku B, Zeitzer JM. Standing Balance and Spatiotemporal Aspects of Gait Are Impaired Upon Nocturnal Awakening in Healthy Late Middle-Aged and Older Adults. J Clin Sleep Med. 2016 Nov 15;12(11):1477-1486. doi: 10.5664/jcsm.6270.
Results Reference
result

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

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