An interventional study of White light exposure and Dim white light exposure in Falls, Balance and Insomnia, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Basic science
To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.
1,930 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's enrollment of 21 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Of its 210 completed or terminated interventional studies of FDA-regulated products, 183 (87%) have results posted.
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Exclusion Criteria:
13 minutes of light at night (2 hours after bedtime)
Behavioral: White light exposure · Behavioral: Dim white light exposure · Behavioral: Very dim white light exposure · Behavioral: Dim orange light exposure
\~200 lux of broad spectrum white light
\~28 lux of broad spectrum white light
\<0.5 lux of broad spectrum white light
\~28 lux of orange light
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
| Milestone | Light Exposure |
|---|---|
| Started | 21 |
| Completed | 17 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 4 |
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.
| %CV | Light Exposure |
|---|---|
| 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 |
Collected over Adverse event data were collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Light Exposure | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Continuous(years) | Light Exposure |
|---|---|
| Mean | 64.7 ± 8.0 |
| Sex: Female, Male(Participants) | Light Exposure |
|---|---|
| Female | 11 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Light Exposure |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 18 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Light Exposure |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 15 |
| More than one race | 2 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Light Exposure |
|---|---|
| United States | 21 |
| Body Mass Index(kg/m²) | Light Exposure |
|---|---|
| Mean | 26.9 ± 6.1 |
| Baseline total sleep time(hours) | Light Exposure |
|---|---|
| Mean | 7.32 ± .73 |
| Baseline sleep efficiency(% of time in bed person is asleep) | Light Exposure |
|---|---|
| Mean | 91.9 ± 5.6 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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