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

Not Applicable

Recruiting

• Conditions: Sleep; Alzheimer Disease; Aging; Cognitive Impairment; CBT
• Interventions: Behavioral: Sleep intervention; Behavioral: Placebo intervention

• Registration Number: NCT03256539
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-22
• Study Start: 2021-08-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-01
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Intervention	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 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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Sleep as assessed by actigraphy	Through study completion, an average of 1 year	Week-long measurement using wrist actigraphy
Cognitive function assessed by standard neurocognitive battery	Through study completion, an average of 1 year

Trial Locations

Locations (1)

UCSF; 🇺🇸 San Francisco, California, United States