Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of AD
|ClinicalTrials.gov Identifier: NCT01920672|
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : December 12, 2017
Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). Sleep efficiency in AD patients is severely impaired and complicated by frequent night awakenings and nocturnal restlessness. Untreated sleep disruption in AD patients is associated with increased rates of neuropsychiatric symptoms, daytime napping, 'sundowning' behaviors, cognitive and functional decline, and morbidity and mortality. The added strain of sleep disruption is the primary reason family caregivers make the decision to institutionalize AD patients. The circadian abnormalities in the sleep-wake cycle commonly observed in AD patients occur more often in individuals with hypothalamic/ pituitary/adrenal (HPA) axis hyperactivity. HPA axis hyperactivity may influence diurnal sleep-wake activity by diminishing an AD patient's ability to respond to external zeitgebers which, in turn, can further propagate HPA axis dysfunction. Thus, interventions to normalize diurnal HPA axis patterns may be beneficial in treating sleep-wake disturbances. Nonpharmacologic treatments are the first line therapy in AD patients with sleep wake problems, given the ineffective and potentially harmful effects of pharmacologic agents. Current clinical sleep hygiene practices in institutional (e.g., nursing home) settings holds promise for reducing disruptive sleep by reestablishing circadian patterns in HPA functioning. These interventions include use of timed and planned activities during daylight hours and creating a relaxing environment in the evening. However little systematic work has been done to determine the efficacy of these interventions in the home setting (where most individuals with AD reside).
We propose a pilot study to (a) characterize objective sleep parameters and behavioral symptoms of sleep-wake disturbance, and biological indicators of diurnal HPA axis activity in a sample of community residing older adults with AD: (b) examine the effects of timed and planned activities on subjective and objective characteristics of sleep, behavioral symptoms, and HPA status; and (c) evaluate measurement approaches in home-dwelling AD patients. Subjective (CG questionnaires) and objective (wrist actigraphy) characteristics of sleep and behavioral symptoms will be measured in fifty-four AD patients being cared for at home by a family. Patients and CG with then be randomized to receive an intervention of timed, planned activities (TPA) or attention control (AC) condition. We will also obtain diurnal measures of HPA activity including salivary cortisol and alpha amylase.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Behavioral: Timed Planned Activity Behavioral: Home Safety and Education Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of Alzheimer's Disease (AD)|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Timed Planned Activity (TPA)
The TPA provides meaningful activities delivered at specific times in the daily diurnal cycle; it is theory-based, its components have been tested in pilot work; and it is portable and replicable (e..g, protocols are standardized). It involves involved 8 contacts (6 home visits and 2 phone calls) over 4 days. At baseline the CG completes the Pleasant Event Activity Survey. From the survey a careplan of meaningful activities are developed for the CG to administer. The suggested activities match the capabilities of an individual with moderate stage AD ie., based on repetitive motion (e.g., folding towels) and integrating multi-sensory stimulation (e.g., soft music, objects pleasant to touch). CG are instructed to introduce these activities during the late morning and early evening.
Behavioral: Timed Planned Activity
Active Comparator: Home Safety and Education Program
The active comparator intervention will be delivered by interventionists who will provide social attention, empathy and engagement similar to that afforded to the experimental group. The length of time spent will be comparable to the length of time spent in the treatment arm. The attention-control group will involve 6 in-home visits in the afternoon and 2 brief telephone education sessions in the morning. Control group subjects will be provided a copy of Mace and Rabins, The 36-Hour Day, a well-known practical guidebook for families caring for AD patients. Each contact will provide helpful education based on a specific book chapter including information about home safety, health promotion, and advanced care planning
Behavioral: Home Safety and Education Program
- total sleep time [ Time Frame: 10 days ]total minutes of sleep
- Wake after sleep onset [ Time Frame: 10 days ]number of episodes of wake activity after "lights out"
- Day/night sleep ratio [ Time Frame: 10 days ]minutes of daytime sleep/ minutes of nighttime sleep
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920672
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Nancy A Hodgson, PhD||Johns Hopkins Univeristy|