SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid

  • STATUS
    Recruiting
  • End date
    Jan 27, 2023
  • participants needed
    200
  • sponsor
    University of Kansas Medical Center
Updated on 27 May 2021
behavior therapy
dementia
cognitive therapy
cognitive behavioral therapy for insomnia
initial insomnia

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 A 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 A accumulation from baseline to one-year post-intervention.

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 A plaques and tau tangles in the brain, and growing evidence shows impaired sleep contributes to the accumulation of A. 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.

Details
Condition Insomnia
Treatment Active control, Cognitive Behavioral Therapy for Insomnia (CBT-I), Sleep and Lifestyle Education
Clinical Study IdentifierNCT03954210
SponsorUniversity of Kansas Medical Center
Last Modified on27 May 2021

Eligibility

Yes No Not Sure

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
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