Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of AD

Alzheimer's Disease Clinical Trial

Official title:

Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of Alzheimer's Disease (AD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920672
• Other study ID #: NA_00088139
• Secondary ID: P30NR014131
• Status: Completed
• Phase: N/A
• First received: August 6, 2013
• Last updated: December 8, 2017
• Start date: September 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

Inclusion Criteria:

• The inclusion/exclusion criteria are designed to obtain a sample of moderate stage AD patients because the sleep disruption we seek to assess occur most frequently at this stage. AD patients must: 1) have a diagnosis of probable AD (physician generated); 2) be over age 60; 3) be able to provide saliva samples; 4) be able to tolerate wrist actigraphy per caregiver report. Family caregivers must: 1) be English speaking; 2) have provided care for a minimum of 3 months; and 3) be the primary caregiver (self-identifies as providing the most day-to-day care).

Exclusion Criteria:

• To minimize the contribution of extraneous variables, subjects will be excluded for the following: regular use of medications with substantial known effects on the measurement of alpha amylase and cortisol (e.g. corticosteroids, interferons, beta-blockers, cytotoxic chemotherapy); major surgery in the past 3 months; history of major psychiatric and/or personality disorder; history of heavy cigarette smoking (e.g. >than 50 pack years); loss of a loved one in the past 3 months. Conditions known to affect measurement of sleep will also be excluded: use of sedatives/ hypnotics, Huntington's' disease, normal pressure hydrocephalus, Parkinson's disease, advanced heart failure (New York Heart Stage 3-4), morbid obesity (BMI > 35), and indications of restless legs syndrome or periodic limb movement disorder. We will exclude subjects screening positive for sleep apnea (actigraph/pulse oximetry oxygen desaturation index > 15).

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Behavioral Symptoms

Intervention

Behavioral:
• Timed Planned Activity

• Home Safety and Education Program

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Day/night sleep ratio	minutes of daytime sleep/ minutes of nighttime sleep	10 days
Primary	total sleep time	total minutes of sleep	10 days
Secondary	Wake after sleep onset	number of episodes of wake activity after "lights out"	10 days