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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01350505
Enrollment
21
Registered
2011-05-09
Start date
2013-10-15
Completion date
2017-06-30
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Balance, Falls, Insomnia

Keywords

Postural Balance, Sleep Initiation and Maintenance Disorders

Brief summary

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

Interventions

BEHAVIORALWhite light exposure

\ 200 lux of broad spectrum white light

BEHAVIORALDim white light exposure

\ 28 lux of broad spectrum white light

BEHAVIORALVery dim white light exposure

\<0.5 lux of broad spectrum white light

BEHAVIORALDim orange light exposure

\ 28 lux of orange light

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Intervention model description

The order of the interventions were randomized to the four visits.

Eligibility

Sex/Gender
ALL
Age
55 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Balance13 minutesBalance 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Light Exposure
13 minutes of experimental light exposure during the night
21
Total21

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up4

Baseline characteristics

CharacteristicLight Exposure
Age, Continuous64.7 years
STANDARD_DEVIATION 8
Alcohol Use Disorders Identification Test1.5 units on a scale
STANDARD_DEVIATION 1.6
Balance Self-Efficacy Scale97.3 units on a scale
STANDARD_DEVIATION 3
Baseline sleep efficiency91.9 % of time in bed person is asleep
STANDARD_DEVIATION 5.6
Baseline total sleep time7.32 hours
STANDARD_DEVIATION 0.73
Body Mass Index26.9 kg/m²
STANDARD_DEVIATION 6.1
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Geriatric Depression Scale0.6 units on a scale
STANDARD_DEVIATION 0.9
Mini Mental State Examination29.9 units on a scale
STANDARD_DEVIATION 0.3
Pittsburgh Sleep Quality Index2.3 units on a scale
STANDARD_DEVIATION 1.4
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
15 Participants
Region of Enrollment
United States
21 participants
Sex: Female, Male
Female
11 Participants
Sex: Female, Male
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 21
other
Total, other adverse events
0 / 21
serious
Total, serious adverse events
0 / 21

Outcome results

Primary

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.

Time frame: 13 minutes

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

ArmMeasureGroupValue (MEAN)Dispersion
Light ExposureChange in BalanceVery Dim White - Step Length6.66 %CVStandard Deviation 3.08
Light ExposureChange in BalanceDim White - Step Length5.34 %CVStandard Deviation 2
Light ExposureChange in BalanceDim Orange - Step Length5.62 %CVStandard Deviation 2.52
Light ExposureChange in BalanceRoom White - Step Length5.78 %CVStandard Deviation 2.87

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026