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NCT01920672 · ClinicalTrials.gov registry record · NA
Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of AD
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 82
- Enrollment target
NCT01920672: Completed NA study, sponsored by Johns Hopkins University.
NCT01920672 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 82 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01920672, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 82 participants
- Enrollment target
Study 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
Interventions
- BEHAVIORAL Timed Planned Activity
- BEHAVIORAL Home Safety and Education Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01920672
The ClinicalTrials.gov registry entry for NCT01920672 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Timed Planned Activity is the first listed.
NCT01920672 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01920672 about?
NCT01920672 is a clinical study titled "Disrupted Sleep, Neuroendocrine Status and the Behavioral Symptoms of AD". 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 noctur...
What is the current status of trial NCT01920672?
This trial is currently completed. It is a NA study. The enrollment target is 82 participants. The study started on 2013-09. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01920672?
The interventions under investigation include: Timed Planned Activity (BEHAVIORAL), Home Safety and Education Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT01920672?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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