Clinical trial NCT03954210: SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
Official title: SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Cognitive Behavioral Therapy for Insomnia
CBT-I
Alzheimer's
Alzheimer's Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
First posted: 2019-05-17
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the efficacy of a sleep intervention on improving cognitive function in older adults with symptoms of insomnia, determine the association between change in sleep measures and change in cognitive function, and examine the efficacy of the sleep intervention on reducing the rate of Aβ deposition. Participants, ages 60-85, will be randomly assigned to a six-week sleep intervention program. A sub-group of fifty participants will undergo Florbetapir-Positron-emission tomography (PET) imaging during the one-year reassessment to examine the efficacy of the sleep intervention on reducing the rate of Aβ accumulation from baseline to one-year post-intervention.

Detailed description: Lifestyle interventions to increase exercise and improve diet have been the focus of recent clinical trials to potentially prevent Alzheimer's disease (AD). However, despite the strong links between sleep disruptions, cognitive decline, and AD, sleep enhancement has yet to be targeted as a lifestyle intervention to prevent AD. Approximately fifteen percent of AD may be prevented by an efficacious intervention aimed to reduce sleep disturbances and sleep disorders. Chronic insomnia is the most frequent sleep disorder occurring in at least forty percent of older adults. Individuals with insomnia are more likely to be diagnosed with AD and demonstrate a decline in cognitive function at long-term follow-up. AD is characterized by the accumulation of Aβ plaques and tau tangles in the brain, and growing evidence shows impaired sleep contributes to the accumulation of Aβ. An intervention aimed at improving insomnia may represent a critical opportunity for primary prevention to slow cognitive decline and potentially delay the onset of AD. Therefore, the long-term goal of this research agenda is to understand how addressing sleep disturbances, via sleep intervention, may delay the onset of AD.

Eligibility criteria: Inclusion Criteria:

* Report of difficulty falling asleep, maintaining sleep, or waking up too early at least three nights a week for the past six months
* A score of greater than, or equal to, ten on the Insomnia Severity Index
* A score of greater than, or equal to, twenty-five on the Mini-Mental State Examination (MMSE)
* A score of less than, or equal to, two on the Dementia Screening Interview (AD8)

Exclusion Criteria:

* A known untreated sleep disorder (i.e., sleep apnea or restless leg syndrome)
* Currently taking benzodiazepines, non-benzodiazepines, melatonin supplements, or agonists for insomnia
* A score of greater than, or equal to, fifteen on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of any suicidal ideation (an answer of one, two, or three on item number nine of the PHQ-9)
* History of drug or alcohol abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-4) criteria within the last two years
* History of a nervous system disorder (i.e., stroke, Parkinson's Disease)
* Severe mental illness (i.e., Schizophrenia, Bipolar Disorder)
* History of a learning disability or attention-deficit/hyperactivity disorder
* Current, or history of, shift work
* Currently receiving CBT-I treatment
* Unable to hear at a conversational level
* Failure of a near vision test utilizing the Logarithmic Near Visual Acuity Chart

Primary outcomes:
measure: Continuous Performance Test (CPT)
timeFrame: Baseline, 6-Week Reassessment, and One-Year Reassessment
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Baseline, 6-Week Reassessment, and One-Year Reassessment
measure: Stroop Test
timeFrame: Baseline, 6-Week Reassessment, and One-Year Reassessment
measure: Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test
timeFrame: Baseline, 6-Week Reassessment, and One-Year Reassessment
Secondary outcomes:
measure: Polysomnography
timeFrame: Second Pre-Screening/Baseline, 6-Week Reassessment, and One-Year Assessment
Other outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-Screening/Baseline, 6-Week Reassessment and One-Year Reassessment
measure: Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: Baseline, 6-Week Reassessment, and One-Year Reassessment
measure: Sleep Efficacy Scale (SES)
timeFrame: Baseline, 6-Week Reassessment, and One-Year Reassessment
measure: Florbetapir PET Imaging
timeFrame: Baseline and One-Year Assessment
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Baseline and One-Year Assessment
measure: Motivation to Change Sleep Behaviors
timeFrame: Baseline
measure: Mini Mental-State Examination (MMSE)
timeFrame: Second Pre-Screening
measure: Logarithmic Near Visual Acuity Chart
timeFrame: Second Pre-Screening
measure: Apolipoprotein E (APOE) 4 Genotyping
timeFrame: Baseline
measure: Coin in Hand
timeFrame: Baseline, 6-Week Reassessment, and One-Year Reassessment
measure: Grooved Pegboard Test
timeFrame: Baseline, 6-Week Reassessment, and One-Year Reassessment
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Catherine Siengsukon, PT, PhD
role: PRINCIPAL_INVESTIGATOR
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