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

NCT03256539 — Not applicable, Terminated, 15 participants, University of California, San Francisco

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Registry	NCT03256539
Status	Terminated - Unexpected closure of study components -- the digital intervention (CBT-I) was no longer accessible, and alternatives were not feasible.
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, other
Enrollment	15 (Actual)
Sponsor	University of California, San Francisco (Other); collaborators: National Institute on Aging (NIA)
Conditions	Sleep, Alzheimer Disease, Cognitive Impairment, Aging, CBT
Interventions	Sleep intervention, Placebo intervention (Behavioral)
Dates	start 2021-08-12, primary completion 2024-01-31, completion 2024-01-31, first posted 2017-08-22, last updated 2025-11-14
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Sleep Intervention	Experimental	Behavioral: Sleep intervention	Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT)
Placebo intervention	Placebo comparator	Behavioral: 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).

Sleep intervention (Behavioral): Behavioral sleep intervention program
Placebo intervention (Behavioral): 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)

+Outcome measures

Primary outcomes

Number of Participants Enrolled to the Study [Up to 24 weeks following study initiation]
Number of Participants That Complete the Study [Through study completion, up to 34 weeks]

Secondary outcomes

Sleep as Assessed by Actigraphy [Through study completion, up to 34 weeks]: Week-long measurement using wrist actigraphy
Cognitive Function Assessed by Standard Neurocognitive Battery [Through study completion, up to 34 weeks]

+Eligibility

Sex: All, ages: 65 Years to any

Inclusion Criteria:

* ≥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 Criteria:

* 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

+Posted results

Participant flow

Milestone	Sleep Intervention	Placebo Intervention
Started	8	7
Completed	0	0
Not completed	8	7

Outcome results

Number of Participants Enrolled to the Study (Primary), Count of participants, Participants: Sleep Intervention 8; Placebo Intervention 7
Number of Participants That Complete the Study (Primary)
Sleep as Assessed by Actigraphy (Secondary)
Cognitive Function Assessed by Standard Neurocognitive Battery (Secondary)

Adverse events

Time frame: Two years

Arm	Deaths	Serious adverse events	Other adverse events
Sleep Intervention	0/8 (0.0%)	0/8 (0.0%)	0/8 (0.0%)
Placebo Intervention	0/7 (0.0%)	0/7 (0.0%)	0/7 (0.0%)

+Locations (1)

Facility	City	Country	Status
UCSF	San Francisco, California	United States

+Study documents

Study Protocol (PDF, 2023-09-21)
Statistical Analysis Plan (PDF, 2023-09-21)
Informed Consent Form (PDF, 2023-09-21)

+Investigators

Yue Leng, PhD, Principal investigator, University of California, San Francisco

+Funding

NIH grants: K99AG056598, R00AG056598