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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep, Alzheimer Disease, Cognitive Impairment, Aging, CBT

Intervention / Treatment
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* Behavioral: Sleep intervention
* Behavioral: Placebo intervention


Participation Criteria
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Eligibility Criteria
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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 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 DSM-IV), 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Intervention<br>Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT) | Behavioral: Sleep intervention<br>* Behavioral sleep intervention program<br>|
| Placebo Comparator: Placebo intervention<br>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). | Behavioral: Placebo intervention<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants enrolled to the study |  | Up to 24 weeks following study initiation | 
| Number of participants that complete the study |  | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep as assessed by actigraphy | Week-long measurement using wrist actigraphy | Through study completion, an average of 1 year | 
| Cognitive function assessed by standard neurocognitive battery |  | Through study completion, an average of 1 year |