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

University of Kansas

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Sleep and Lifestyle Education; Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03954210

R01AG058530 (U.S. NIH Grant/Contract)

STUDY00143545

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Six-Week CBT-I Program

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Six-Week Sleep and Lifestyle Education Program

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sleep and Lifestyle Education