Background
Poor sleep among residents in nursing homes is common and associated with decreased function and falls. Tunable lighting which mimics both day and night exposure may improve sleep. In this pilot study, we evaluate an assessment strategy to determine the appropriate outcome measure for a future Stage III efficacy trial.
Methods
This pilot study uses a crossover design, in which three hallways were randomized to tunable LED or static lighting for two months (December 2018-January, 2019) and then switched to the other condition for two months (February-March, 2019). Residents who had been in the nursing home for at least 90 days were eligible. We measured sleep (primary) and agitation (secondary) outcomes using key informant interviews and available administrative data. We measured sleep by interviewing staff using the Sleep Disorders Inventory (SDI) and Minimum Data Set (MDS) resident assessments. We measured agitation by interviewing staff using the Cohen-Mansfield Agitation Inventory (CMAI) and MDS assessments. We used McNemar’s test and Wilcoxon matched-pairs signed-ranks tests to compare within-person changes for all measures.
Results
62 residents, 35 of whom had dementia, had complete MDS and SDI data available. The average resident age was 90 and 77% were Asian. The percent of residents with any sleep disturbances was lower in the tuned vs. static lighting conditions based on MDS measure (4.8% tuned, 14.5% static, p < .10); no difference was observed using the SDI (33.9% tuned, 37.1% static). Sleep disturbances were less frequent in the tuned vs. static lighting conditions for both the MDS and SDI measures (p < .10). No significant differences were observed for agitated behaviors.
Conclusions
Results suggest that the available MDS sleep measure under detects disturbances compared to the gold standard staff interview. Efficacy trials should consider staff interview as primary study outcome. Sensitivity to change in the MDS-based sleep measure could be tested in Stage III trial to determine appropriateness for Stage IV, pragmatic trial.