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Behavioral sleep education for Alzheimer's Disease

N/A
Waitlist Available
Led By Yeonsu Song, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AD diagnosis OR probable or possible AD as documented in electronic medical record, which includes Mini Mental State Exam score >12 (indicating mild to moderate severity of AD) and neuroimaging evidence
>1 sleep problem >3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after the last session of the sleep intervention
Awards & highlights

Study Summary

This trial will develop a sleep intervention program specifically for Alzheimer's patients and their caregivers who both experience sleep difficulties.

Eligible Conditions
  • Alzheimer's Disease
  • Sleep

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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of atrophy in hippocampus The patient was diagnosed with probable or possible AD as documented in the electronic medical record, which included a Mini Mental State Exam score >12 (indicating mild to moderate severity of AD) and neuroimaging evidence of atrophy in the hippocampus.
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(NPI-Night) The text discusses a sleep problem that is present three times a week on the Neuropsychiatric Inventory Nighttime Behavior Scale (NPI-Night).
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The person needs to have an eligible caregiver to be able to get the home care services.
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If you are living with an eligible patient, you may be able to get help with your costs
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Helped patient with at least one of six basic activities of daily living (bathing, dressing, toileting, transfers, continence, feeding) or at least one of eight Instrumental activities of daily living (using the telephone, shopping, preparing meals, housekeeping, laundry, transportation, taking medicine, managing money) for the past six months.
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was associated with an increased likelihood of insomnia The Pittsburgh Sleep Quality Index (PSQI) total score >5 was associated with an increased likelihood of insomnia.
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You are aged >60 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after the last session of the sleep intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after the last session of the sleep intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep efficiency for Alzheimer's disease patients
Sleep quality for caregivers
Total wake time for Alzheimer's disease patients
Secondary outcome measures
Caregiver burden for caregivers
Cognitive function for Alzheimer's disease patients
Depression for Alzheimer's disease patients
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Education onlyExperimental Treatment1 Intervention
education on sleep, aging, and dementia but without specific or individualized recommendations
Group II: Behavioral sleep educationExperimental Treatment1 Intervention
manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Education only
2007
N/A
~1170
Behavioral sleep education
2018
N/A
~60

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,521 Previous Clinical Trials
10,278,876 Total Patients Enrolled
Yeonsu Song, PhDPrincipal Investigator - University of California, Los Angeles
University of California, Los Angeles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrolment slots for this medical experiment?

"The data available on clinicaltrials.gov reveals that this medical study is not currently enrolling patients, despite being first posted in September 2018 and last updated in June 2022. Nevertheless, there are 685 other trials actively searching for participants at the moment."

Answered by AI

What beneficial results are researchers hoping to observe with the completion of this trial?

"This research trial will evaluate the effects of a sleep intervention on Caregiver Sleep Quality over a 3 months time frame. The Zarit Burden Interview is used to assess secondary outcomes such as Caregiver Burden, Alzheimer's disease Assessment Scale-Cognitive Subscale for Cognitive Function in those with AD and Cornell Scale for Depression Dementia to measure depression levels."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What site did they apply to?
University of California Los Angeles
What portion of applicants met pre-screening criteria?
Did not meet criteria
~9 spots leftby Mar 2025