SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
- Conditions
- Insomnia
- Interventions
- Behavioral: Sleep and Lifestyle EducationBehavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Registration Number
- NCT03954210
- Lead Sponsor
- University of Kansas Medical Center
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Six-Week Sleep and Lifestyle Education Program Sleep and Lifestyle Education 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. Six-Week CBT-I Program Cognitive Behavioral Therapy for Insomnia (CBT-I) 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.
- Primary Outcome Measures
Name Time Method Stroop Test Baseline, 6-Week Reassessment, and One-Year Reassessment Assessment of participants executive functioning. Participants will be required to inhibit their natural response and replace it with a different response (i.e., reading a word versus saying the color of the word). Scores are obtained by taking the difference between conditions and normalizing for the number of stimuli.
Continuous Performance Test (CPT) Baseline, 6-Week Reassessment, and One-Year Reassessment Assessment of the participants attention. Participants will be given a set of rules for stimuli, and based on those rules they will determine if a presented stimuli fit within those rules. Scores will be determined by the number of correctly identified stimuli.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Baseline, 6-Week Reassessment, and One-Year Reassessment Twelve sub-tests assessing participants immediate memory, visuospatial/constructional, language, attention, and delayed memory skills.Participants will engage in list learning, story memory, figure copying, line orientation, picture naming, semantic fluency, digit span, coding, list recall, list recognition, story memory and figure recall.
Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test Baseline, 6-Week Reassessment, and One-Year Reassessment Assessment of the participants attention and working memory. Participants will be required to remember and recall strings of numbers ranging from three to nine. Primary scores are obtained by tallying the number of trials the participant accurately recalled in the forward direction and the backward direction. Secondary scores are obtained by determining the longest string of numbers the participant recalled in the forward and backward direction.
- Secondary Outcome Measures
Name Time Method Polysomnography Second Pre-Screening/Baseline, 6-Week Reassessment, and One-Year Assessment Assessment to determine if the participants have a sleep disorder. This determination is made by a trained professional utilizing the patient's brain waves, blood oxygen level, heart rate, breathing, and eye and leg movements to determine.
Trial Locations
- Locations (1)
University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
🇺🇸Kansas City, Kansas, United States