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To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | 13 minutes of light at night (2 hours after bedtime) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| White light exposure | Behavioral | ~200 lux of broad spectrum white light |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie M Zeitzer, PhD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27448415 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Light Exposure | 13 minutes of experimental light exposure during the night |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Light Exposure | 13 minutes of experimental light exposure during the night |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Healthy older adults. Note 4 participants declined to participate in the last condition (white room light). | Posted | Mean | Standard Deviation | %CV | 13 minutes |
|
Adverse event data were collected over 1 day
The definition of "adverse" and "serious adverse events" that we used were the same as that on clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Light Exposure | 13 minutes of experimental light exposure during the night | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jamie Zeitzer | VA Palo Alto Health Care System | 650-493-5000 | 62410 | jamie.zeitzer@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2018 | Sep 26, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2018 | Sep 26, 2018 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2016 | Sep 26, 2018 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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The order of the interventions were randomized to the four visits.
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| Dim white light exposure |
| Behavioral |
~28 lux of broad spectrum white light |
|
| Very dim white light exposure | Behavioral | <0.5 lux of broad spectrum white light |
|
| Dim orange light exposure | Behavioral | ~28 lux of orange light |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m² |
|
| Baseline total sleep time | Mean | Standard Deviation | hours |
|
| Baseline sleep efficiency | Mean | Standard Deviation | % of time in bed person is asleep |
|
| Balance Self-Efficacy Scale | 0-100, with higher scores being better balance | Mean | Standard Deviation | units on a scale |
|
| Mini Mental State Examination | 0-30, with higher scores being better overall cognition | Mean | Standard Deviation | units on a scale |
|
| Pittsburgh Sleep Quality Index | 0-21, with higher scores being worse sleep and scores >5 associated with clinically significant sleep problems | Mean | Standard Deviation | units on a scale |
|
| Geriatric Depression Scale | 0-15, with higher scores representing greater depressive symptoms; scores >5 are suggestive of depression and >10 are almost always depression | Mean | Standard Deviation | units on a scale |
|
| Alcohol Use Disorders Identification Test | 0-40, higher scores representing greater risk for alcohol use disorder score: 0-7, Alcohol education score 8-15, Simple advice score 16-19, Simple advice plus brief counseling and continued monitoring score 20-40, Referral to specialist for diagnostic evaluation and treatment | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| D001523 |
| Mental Disorders |