A nonpharmacological intervention to improve sleep in nursing home patients: results of a controlled clinical trial.

Objectives: To improve nighttime sleep in nursing home patients.
Design: Controlled clinical trial.
Setting: Eight community nursing homes enrolled two at a time.
Participants: Of 1,077 patients assessed in the eight nursing homes, 638 (59%) were eligible, and consent was obtained for 273 (43% of those eligible). Of the 230 who underwent baseline assessments, 173 completed the immediate-intervention phase of the trial (77 in the intervention group and 96 in the control group). A total of 160 subjects completed the intervention (77 in the immediate-intervention group and 83 in the delayed-intervention phase).
Intervention: Trained research staff provided the intervention, which included daytime physical activity and attempts to keep subjects out of bed, evening bright light exposure, a consistent bedtime routine, nighttime care routines designed to minimize sleep disruption, and strategies to reduce nighttime noise. Subjects from one nursing home received the intervention (Group 1), whereas subjects in the second nursing home served as a control group (Group 2); then Group 2 received the intervention.
Measurements: Primary outcomes included measures of sleep recorded using wrist actigraphy in all subjects and polysomnography in a subgroup of subjects. Secondary measures included assessments of mood and behavior using the Neuropsychiatric Inventory, the Geriatric Depression Scale, and behavioral observations.
Results: There were no significant differences in any of the primary actigraphic sleep outcome measures between the intervention and control group after the immediate-intervention phase of the trial. In the 160 subjects who completed the intervention, there were no significant changes in any actigraphic measure of nighttime sleep, nor were there any significant changes in measures of sleep in the 45 subjects who had baseline and intervention polysomnography.
Conclusion: This multicomponent, nonpharmacological intervention conducted by trained research staff had no effect on nighttime sleep in this sample of nursing home patients. Enhanced nonpharmacological interventions should be developed and tested and combined with environmental interventions to mitigate noise when feasible. Adjunctive drug therapy may be needed to improve sleep in a substantial proportion of this population and should be tested in addition to nonpharmacological interventions in rigorous clinical trials.