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NCT02967185.

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Study Objectives: Sleep variability is a clinically significant variable in understanding and treating insomnia in older adults. The current study examined changes in sleep variability in the course of brief behavioral therapy for insomnia (BBT-I) in older adults who had chronic insomnia. Additionally, the current study examined the mediating mechanisms underlying reductions of sleep variability and the moderating effects of baseline sleep variability on treatment responsiveness. Methods: Sixty-two elderly participants were randomly assigned to either BBT-I or self-monitoring and attention control (SMAC). Sleep was assessed by sleep diaries and actigraphy from baseline to posttreatment and at 3-month follow-up. Mixed models were used to examine changes in sleep variability (within-person standard deviations of weekly sleep parameters) and the hypothesized mediation and moderation effects. Results: Variabilities in sleep diary-assessed sleep onset latency (SOL) and actigraphy-assessed total sleep time (TST) significantly decreased in BBT-I compared to SMAC (Pseudo R 2 = .12, .27; P = .018, .008). These effects were mediated by reductions in bedtime and wake time variability and time in bed. Significant time × group × baseline sleep variability interactions on sleep outcomes indicated that participants who had higher baseline sleep variability were more responsive to BBT-I; their actigraphy-assessed TST, SOL, and sleep efficiency improved to a greater degree (Pseudo R 2 = .15 to .66; P < .001 to .044). Conclusions I NTRO DUCTI O NChronic insomnia is the most prevalent sleep disorder and affects 15% to 35% of older adults.1-3 Recent research suggests that night-to-night sleep variability is an important clinical characteristic and therapeutic target in treating insomnia in older adults. 4,5 Higher objective sleep variability is associated with poorer subjective sleep quality, 4,6,7 poorer subjective well-being, 7 and greater risks of cardiometabolic diseases 5,6 in older adults with chronic insomnia. Although objective sleep is often found to be similar in those with and without insomnia, significantly greater sleep variability was observed in older adults with insomnia than in older adults without insomnia. 5,7 Although evidence supports the clinical significance of sleep variability in understanding and treating insomnia, little is known with regard to changes in sleep variability in the treatment of insomnia for older adults, the mechanisms by which changes in sleep variability occur, and the clinical significance of sleep variability in Reduction of sleep variability in the treatment of insomnia has been observed in young and middle-aged adults following BRIEF SUMMARY Current Knowledge/Study Rationale: High night-to-night sleep variability is prevalent in older adults who have chronic insomnia, is associated with poorer health outcomes, and may maintain insomnia. It is unclear if and how sleep variability decreases over the course of a brief behavioral therapy for insomnia (BBT-I) and whether pretreatment slee...

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