Trial Outcomes & Findings for Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia (NCT NCT01350505)

NCT ID: NCT01350505

Last Updated: 2019-02-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 13 minutes
• Results posted on: 2019-02-15

Participant Flow

Participant milestones

Measure	Light Exposure 13 minutes of experimental light exposure during the night
Overall Study STARTED	21
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Light Exposure 13 minutes of experimental light exposure during the night
Overall Study Lost to Follow-up	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Light Exposure n=21 Participants 13 minutes of experimental light exposure during the night
Age, Continuous	64.7 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
Body Mass Index	26.9 kg/m² STANDARD_DEVIATION 6.1 • n=5 Participants
Baseline total sleep time	7.32 hours STANDARD_DEVIATION .73 • n=5 Participants
Baseline sleep efficiency	91.9 % of time in bed person is asleep STANDARD_DEVIATION 5.6 • n=5 Participants
Balance Self-Efficacy Scale	97.3 units on a scale STANDARD_DEVIATION 3.0 • n=5 Participants
Mini Mental State Examination	29.9 units on a scale STANDARD_DEVIATION 0.3 • n=5 Participants
Pittsburgh Sleep Quality Index	2.3 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants
Geriatric Depression Scale	0.6 units on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
Alcohol Use Disorders Identification Test	1.5 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants

PRIMARY outcome

Timeframe: 13 minutes

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

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.

Outcome measures

Measure	Light Exposure n=21 Participants 13 minutes of experimental light exposure during the night
Change in Balance Very Dim White - Step Length	6.66 %CV Standard Deviation 3.08
Change in Balance Dim White - Step Length	5.34 %CV Standard Deviation 2.00
Change in Balance Room White - Step Length	5.78 %CV Standard Deviation 2.87
Change in Balance Dim Orange - Step Length	5.62 %CV Standard Deviation 2.52

Adverse Events

Light Exposure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jamie Zeitzer

VA Palo Alto Health Care System

Phone: 650-493-5000

Email: jamie.zeitzer@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place