Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease
NCT ID: NCT03256539
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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TERMINATED
NA
15 participants
INTERVENTIONAL
2021-08-12
2024-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Sleep Intervention
Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT)
Sleep intervention
Behavioral sleep intervention program
Placebo intervention
Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration).
Placebo intervention
Quasi-desensitization intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration)
Interventions
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Sleep intervention
Behavioral sleep intervention program
Placebo intervention
Quasi-desensitization intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration)
Eligibility Criteria
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Inclusion Criteria
* Memory complaints verified by an informant
* Clinical diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease
* General cognitive performance sufficiently persevered such that a diagnosis of Alzheimer's disease cannot be made by the site physician
* No evidence (CT or MRI scans within 12 months prior to screening) of infection, infarction, or other focal lesions and no clinical symptoms suggestive of intervening neurological disease
* Adequate visual and auditory acuity to allow neuropsychological testing
* Meets International Classification of Sleep Disorders-2nd edition (ICSD-2) criteria for insomnia or circadian rhythm disorders, or shows actigraphy evidence of sleep disturbances and excessive napping
Exclusion Criteria
* Any comorbid psychiatric conditions or severe personality disorder within the past 2 years (by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition), such as major depression, bipolar disorder, schizophrenia and other psychotic features
* Any uncontrolled medical conditions or systemic illness that might lead to difficulty complying with the study protocol
* History of alcohol or substance abuse within the past 2 years
* Any inadequately treated primary or secondary sleep disorder (due to medical conditions) that might confound the association
65 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Yue Leng, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF
San Francisco, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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