SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
NCT ID: NCT03954210
Last Updated: 2025-07-17
Study Results
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Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2019-08-27
2025-04-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Six-Week CBT-I Program
CBT-I, six sessions, forty-five to sixty minutes in duration.
Session 1: set up sleep restriction and stimulus control, discuss strategies for how to stay awake to a prescribed hour and what to do with wake after onset sleep time, provide sleep hygiene education.
Session 2: determine if upward titration of total sleep time is warranted, review sleep hygiene.
Session 3: continue upward titration of total sleep time, cognitive therapy for negative sleep beliefs if indicated.
Session 4: continue upward titration of total sleep time, follow-up regarding negative sleep beliefs.
Session 5: continue upward titration of total sleep time, discuss relapse prevention.
Session 6: assess global treatment gains, discuss questions regarding relapse prevention.
Cognitive Behavioral Therapy for Insomnia (CBT-I)
CBT-I is an in-person, one-on-one program with a graduate psychology research assistant who is trained in providing a standardized CBT-I. Participants will maintain a sleep diary during the course of the program to aid in tailoring the program. Each session will begin with a summary and graphing of sleep diary data and will include an assessment of treatment gains and adherence.
Six-Week Sleep and Lifestyle Education Program
Sleep and Lifestyle Education, six sessions, forty-five to sixty minutes in duration.
Session 1: Sleep education, Instruction/demonstration on stretching exercises.
Session 2: Education on environmental factors \& sleeping positions that impact sleep.
Session 3: Education on lifestyle factors that impact sleep.
Session 4: Education on diet and sleep.
Session 5: Education on exercises and sleep.
Session 6: Discus maintaining achievements \& preventing relapses.
Sleep and Lifestyle Education
Participants in the sleep and lifestyle education group will attend six weekly, in-person, one-on-one, stretching, and thinking activity sessions with a graduate research assistant to control for socialization and contact with research personnel.
Interventions
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Cognitive Behavioral Therapy for Insomnia (CBT-I)
CBT-I is an in-person, one-on-one program with a graduate psychology research assistant who is trained in providing a standardized CBT-I. Participants will maintain a sleep diary during the course of the program to aid in tailoring the program. Each session will begin with a summary and graphing of sleep diary data and will include an assessment of treatment gains and adherence.
Sleep and Lifestyle Education
Participants in the sleep and lifestyle education group will attend six weekly, in-person, one-on-one, stretching, and thinking activity sessions with a graduate research assistant to control for socialization and contact with research personnel.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
85 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
National Institutes of Health (NIH)
NIH
University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Catherine Siengsukon, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
Kansas City, Kansas, United States
Countries
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References
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Other Identifiers
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STUDY00143545
Identifier Type: -
Identifier Source: org_study_id
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