Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of AD
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Behavioral Symptoms
Study type: Interventional

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.
    


Intervention name(s): Timed Planned Activity; Home Safety and Education Program
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care