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Sleep Intervention to Enhance Cognitive Status and Reduce Beta-Amyloid (SIESTA)

Recruiting

This study will investigate the effects of cognitive behavioral training for insomnia (CBT-I) on improving cognitive function and reducing beta-amyloid accumulation in older adults with insomnia. Beta-amyloid is a protein that builds up in the brains of people with Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years 85 Years All Yes
August 27, 2019
September 2020
200

  • Difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights a week for the past 6 months
  • Insomnia Severity Index score of 10 or greater 
  • Mini-Mental State Examination score of 25 or greater
  • Dementia Screening Interview score of 2 or less

  • Known untreated sleep disorder, such as sleep apnea or restless leg syndrome
  • Currently taking benzodiazepines, nonbenzodiazepines, melatonin supplements, or agonists for insomnia
  • Severe depression (Patient Health Questionnaire score of 15 or more) or suicidal ideation
  • History of drug or alcohol abuse in past 2 years
  • History of a nervous system disorder, such as stroke or Parkinson's disease
  • Severe mental illness, such as schizophrenia or bipolar disorder
  • History of a learning disability or attention-deficit/hyperactivity disorder
  • Current or previous shift work
  • Currently or previously received CBT-I
  • Unable to hear at a conversational level
  • Failure of a near vision test

CBT-I therapy is designed to improve sleep by addressing the sleep environment, schedules, behaviors, and thoughts a person has. Participants will be randomly assigned to either one-on-one CBT-I training or to stretching and thinking activities for 6 weeks. Sessions will be 45 to 60 minutes long once per week. Participants in the CBT-I group will also maintain a sleep diary. A subgroup of CBT-I participants will undergo positron emission tomography imaging at the 1-year reassessment to examine the effects of training on reducing the accumulation of proteins associated with Alzheimer's disease.

Name City State Zip Status Primary Contact
University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
Kansas City Kansas 66160 Recruiting Eryen Nelson, MPH
913-585-7349
enelson5@kumc.edu

University of Kansas Medical Center

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Name Role Affiliation
Catherine Siengsukon, PT, PhD Principal Investigator University of Kansas Medical Center

Name Phone Email
Eryen Nelson, MPH (913) 585-7349 enelson5@kumc.edu

NCT03954210

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