Status:
COMPLETED
Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of AD
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60-100 years
Phase:
NA
Brief 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 ef...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01920672
Start Date
September 1 2013
End Date
June 1 2015
Last Update
December 12 2017
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205