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

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. CBT-I is an efficacious treatment for insomnia, but the use of CBT-I to improve cognitive function and potentially reduce the rate of Aβ accumulation has never been examined. Therefore, the long-term goal of this research agenda is to understand how addressing sleep disturbances may delay the onset of AD.

If you are interested in participating, please click this link to complete a brief survey: https://redcap.kumc.edu/surveys/?s=XTT8HCC4NN

Eligibility Criteria

• Male or Females between 60 -85 Years

• 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, or has received, CBT-I treatment

• Unable to hear at a conversational level

• Failure of a near vision test utilizing the Logarithmic Near Visual Acuity Chart

Principal Investigator

Catherine Siengsukon, PT, PhD

Study Contact

Eryen Nelson, (913) 945-7349, enelson5@kumc.edu

Estimated Completion Date

Monday, August 10, 2020

ClinicalTrials.gov #

NCT03954210
07/31/2019