Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of AD
NCT01920672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2017-12-12
Summary
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.
Conditions
Interventions
- BEHAVIORAL
-
Timed Planned Activity
- BEHAVIORAL
-
Home Safety and Education Program
Sponsors & Collaborators
-
National Institute of Nursing Research (NINR)
collaborator NIH - lead OTHER
Principal Investigators
-
Nancy A Hodgson, PhD · Johns Hopkins Univeristy
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 60 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2015-06-30
- Completion
- 2015-06-30
Countries
- United States
Study Locations
More Related Trials
-
Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance
NCT01061242 ·Status: COMPLETED ·Phase: NA
-
Assessment of a Behavioral Sleep Program in a Population With Sleep Disturbances
NCT05872672 ·Status: COMPLETED ·Phase: NA
-
Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
NCT03256539 ·Status: TERMINATED ·Phase: NA
-
Effect of Activity on Sleep of Cognitively-Impaired Veterans
NCT00013182 ·Status: COMPLETED ·Phase: NA
-
Sleep-dependent Learning in Aging
NCT03840083 ·Status: RECRUITING ·Phase: NA
-
Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease
NCT05649514 ·Status: RECRUITING ·Phase: NA
-
Improving Sleep Using Mentored Behavioral and Environmental Restructuring
NCT03327324 ·Status: COMPLETED ·Phase: NA
-
Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia
NCT00178568 ·Status: COMPLETED
-
Sleep, Cognition and Memory Disorder
NCT01650454 ·Status: COMPLETED ·Phase: NA
-
Sleep Disruption in Post-operative Patients in the Neurocritical Care Unit
NCT02997839 ·Status: TERMINATED ·Phase: NA
-
Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment
NCT03912571 ·Status: COMPLETED
-
Improving Sleep in Veterans and Their CGs
NCT02057068 ·Status: COMPLETED ·Phase: NA
-
Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation
NCT04992676 ·Status: COMPLETED
-
Sleep Hygiene Intervention on Sleep Quality Improvement in Elders With Parkinson's Disease
NCT06937632 ·Status: COMPLETED ·Phase: NA
-
Leveraging Social Networks to Improve Sleep and Mindfulness Among Older Adults in Residential Housing Facilities
NCT06989619 ·Status: RECRUITING ·Phase: NA
-
The Peripheral Blood Multi-Omics Study on Sleep Loss
NCT06492109 ·Status: RECRUITING ·Phase: NA
-
Behavioral and Sleep Hygiene Education With Mindfulness Intervention to Improve Sleep Regularity in Adolescents
NCT06028997 ·Status: COMPLETED ·Phase: NA
-
Sleep Quality in Assisted-Living Residents
NCT04400617 ·Status: RECRUITING
-
Does Acoustic Stimulation During Sleep Boost Slow Wave Sleep and Memory Performance?
NCT04277104 ·Status: COMPLETED ·Phase: NA
-
Sleep as a Mechanism of Change in Alcohol Use
NCT06286774 ·Status: RECRUITING ·Phase: NA
-
Behavioral Sleep Intervention in Children With Disruptive Behaviors
NCT02783560 ·Status: COMPLETED ·Phase: NA
-
Improving Sleep Continuity Through Mindfulness Training for Better Cognitive Ageing.
NCT03677726 ·Status: COMPLETED ·Phase: NA
-
Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance
NCT00438438 ·Status: COMPLETED ·Phase: NA
-
Sleep Health Enhancement in Midlife Adults
NCT06311500 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics
NCT01194713 ·Status: COMPLETED ·Phase: NA