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TerminatedNo phase

Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease

Reason given: Unexpected closure of study components -- the digital intervention (CBT-I) was no longer accessible, and alternatives were not feasible.

Key facts

Where
San Francisco, United StatesSee the site

Where in United States

  • UCSFSan Francisco, United StatesNo longer taking part

Trial details

Who runs it
University of California, San Francisco
Trial code
NCT03256539
Record updated
14 November 2025
Original description
This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light therapy and a modified cognitive behavioral therapy for insomnia will be developed to address 24-hour patterns of sleep. We will then pilot test its feasibility and explore its preliminary effects on improving sleep/napping and cognition in patients with MCI or mild Alzheimer's disease.Read full original descriptionShow less

This study aimed to pilot test a non-pharmacological (behavioral) treatment program targeting improved cognition through improving 24-h sleep-wake cycle in people with mild cognitive impairment (MCI) or mild Alzheimer's disease. A treatment program incorporating bright light therapy and a modified cognitive behavioral therapy for insomnia will be developed to address 24-hour patterns of sleep. We will then pilot test its feasibility and explore its preliminary effects on improving sleep/napping and cognition in patients with MCI or mild Alzheimer's disease.

Inclusion: ≥65 years old; 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: Any major neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, multiple sclerosis, seizure disorder, Huntington's disease, brain tumor or history of significant head trauma; 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.

ClinicalTrials.gov NCT03256539