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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01350505
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Actual Duration (Months): 44.5
• Patients Per Site Per Month: 0.5

Study Details

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	Phase
Falls; Balance; Insomnia; Aging	Behavioral: White light exposure; Behavioral: Dim white light exposure; Behavioral: Very dim white light exposure; Behavioral: Dim orange light exposure	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Intervention Model: Crossover Assignment
• Intervention Model Description: The order of the interventions were randomized to the four visits.The order of the interventions were randomized to the four visits.
• 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: Oct 15, 2013
• Actual Primary Completion Date: Jan 31, 2017
• Actual Study Completion Date: Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All subjects 13 minutes of light at night (2 hours after bedtime)	Behavioral: White light exposure; ~200 lux of broad spectrum white light; Behavioral: Dim white light exposure; ~28 lux of broad spectrum white light; Behavioral: Very dim white light exposure; <0.5 lux of broad spectrum white light; Behavioral: Dim orange light exposure; ~28 lux of orange light

Outcome Measures

Primary Outcome Measures

1. Change in Balance [13 minutes]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California	United States	94304-1290

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

Study Documents (Full-Text)

• Study Protocol - Sep 26, 2018
• Statistical Analysis Plan - Sep 26, 2018
• Informed Consent Form - Aug 31, 2016

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01350505
• Other Study ID Numbers: E0773-P
• First Posted: May 9, 2011
• Last Update Posted: Feb 15, 2019
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• 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

Study Results

Participant Flow

Arm/Group Title	Light Exposure
Arm/Group Description	13 minutes of experimental light exposure during the night
Period Title: Overall Study
STARTED	21
COMPLETED	17
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Light Exposure
Arm/Group Description	13 minutes of experimental light exposure during the night
Overall Participants	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.7 (8.0)
Sex: Female, Male (Count of Participants)
Female	11 52.4%
Male	10 47.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 14.3%
Not Hispanic or Latino	18 85.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 4.8%
Asian	1 4.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 4.8%
White	15 71.4%
More than one race	2 9.5%
Unknown or Not Reported	1 4.8%
Region of Enrollment (participants) [Number]
United States	21 100%
Body Mass Index (kg/m²) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m²]	26.9 (6.1)
Baseline total sleep time (hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hours]	7.32 (.73)
Baseline sleep efficiency (% of time in bed person is asleep) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [% of time in bed person is asleep]	91.9 (5.6)
Balance Self-Efficacy Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	97.3 (3.0)
Mini Mental State Examination (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	29.9 (0.3)
Pittsburgh Sleep Quality Index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.3 (1.4)
Geriatric Depression Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	0.6 (0.9)
Alcohol Use Disorders Identification Test (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.5 (1.6)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Healthy older adults. Note 4 participants declined to participate in the last condition (white room light).

Arm/Group Title	Light Exposure
Arm/Group Description	13 minutes of experimental light exposure during the night
Measure Participants	21
Very Dim White - Step Length	6.66 (3.08)
Dim White - Step Length	5.34 (2.00)
Dim Orange - Step Length	5.62 (2.52)
Room White - Step Length	5.78 (2.87)

Adverse Events

Time Frame	Adverse event data were collected over 1 day
Adverse Event Reporting Description	The definition of "adverse" and "serious adverse events" that we used were the same as that on clinicaltrials.gov.
Arm/Group Title	Light Exposure
Arm/Group Description	13 minutes of experimental light exposure during the night
All Cause Mortality
	Light Exposure
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Serious Adverse Events
	Light Exposure
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Other (Not Including Serious) Adverse Events
	Light Exposure
	Affected / at Risk (%)	# Events
Total	0/21 (0%)

Limitations/Caveats

Tested only at a single, approximate circadian phase Did not have a large enough sample size to discriminate the effect of awakening out of different sleep stages or the impact of factors such as age, sex, and race

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.