Abstract
BackgroundSleep-wake disorders occur in most persons living with dementia and include late afternoon or evening agitation, irregular sleep-wake rhythms such as daytime hypersomnia, frequent night awakenings, and poor sleep efficiency. Sleep-wake disorders pose a great burden to family caregivers, and are the principal causes of distress, poor quality of life, and institutionalization. Regulating the sleep-wake cycle through the use of light and activity has been shown to alter core clock processes and suggests that a combination of cognitive, physical, and sensory-based activities, delivered at strategic times, may be an effective mechanism through which to reduce sleep-wake disorders.MethodsA definitive Phase III efficacy trial of the Healthy Patterns intervention, a home-based activity intervention designed to improve sleep-wake disorders and quality of life, is being conducted using a randomized two-group parallel design of 200 people living with dementia and their caregivers (dyads). Specific components of this one-month, home-based intervention involve 4 in-home visits and includes: 1) assessing individuals’ functional status and interests; 2) educating caregivers on environmental cues to promote activity and sleep; and 3) training caregivers in using timed morning, afternoon, and evening activities based on circadian needs across the day. The patient focused outcomes of interest are quality of life, measures of sleep assessed by objective and subjective indicators including actigraphy, subjective sleep quality, and the presence of neuropsychiatric symptoms. Caregiver outcomes of interest are quality of life, burden, confidence using activities, and sleep disruption. Salivary measures of cortisol and melatonin are collected to assess potential intervention mechanisms.DiscussionThe results from the ongoing study will provide fundamental new knowledge regarding the effects of timing activity participation based on diurnal needs and the mechanisms underlying timed interventions which can lead to a structured, replicable treatment protocol for use with this growing population of persons living with dementia.Clinical trial registrationClinicaltrials.gov # NCT03682185 at https://clinicaltrials.gov/; Date of clinical trial registration: 24 September 2018.
Highlights
Sleep-wake disorders occur in most persons living with dementia and include late afternoon or evening agitation, irregular sleep-wake rhythms such as daytime hypersomnia, frequent night awakenings, and poor sleep efficiency
We hypothesize that scheduling activities based on shifting diurnal patterns across the day such as using cognitively stimulating activities in the mid-morning hours, physically stimulating activities in the afternoon hours and relaxing activities in the evening hours may help to reduce sleep-wake disruption in home dwelling persons living with dementia (PLWD)
The success of the Healthy Patterns intervention will be measured by its impact on outcomes including measures of quality of life (QOL) and Sleep-wake disorders (SWD) symptoms, including waking after sleep onset, day/night sleep ratio, and total sleep time
Summary
Study design Reporting the design of this study follows CONSORT guidelines [26]. The study is a two-group, randomized, parallel design, clinical trial of 200 dyads of persons with dementia and their primary family caregiver. Interested dementia caregivers who contact the research team will be screened for eligibility by telephone Those dyads initially eligible will receive a nurse assessment to obtain written informed consent and to rule out primary sleep disorders requiring specialty care. Persons screened potentially eligible by telephone and willing to participate will be scheduled to receive a home assessment and verbal consent visit by a study nurse within a 10-day window. Intervention The Healthy Patterns group will involve 4 in-home visits in the mid-morning and up to 4 brief telephone education sessions in the evening provided over 4 weeks. Aim 1 To analyze the effects of the timed intervention on our primary outcomes difference scores (T2 -T1) will be calculated for each participant and these change scores will be analyzed as a function of the treatment group, with the baseline observation (T1) serving as a covariate. Our approach will provide sensitive analyses that determine whether the interventions impact on 1-month change in SWD symptoms is partly due to its effect on 1-month change in cortisol
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
