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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03954210
• Other study ID #: STUDY00143545
• Secondary ID: R01AG058530
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 2025
• Est. primary completion date: April 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center- Sleep, Health and Wellness Laboratory	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Health Questionnaire (PHQ-9)	Assessment of patients depression over the past two weeks. There are nine items that yield a maximum score of twenty-seven. Each item is anchored on a four-point scale with 0 being "Not at all" and 3 being "Nearly Everyday." Participants can demonstrate a minimum score of zero (no depression) or twenty-seven (severe depression). The tenth item that assesses how depressive symptoms affect functional level will not be utilized.	Pre-Screening/Baseline, 6-Week Reassessment and One-Year Reassessment
Other	Generalized Anxiety Disorder Assessment (GAD-7)	Assessment of patients anxiety over the past two weeks. There are eight items anchored on a scale of zero ("Not at all") to three ("Nearly Everyday"), that yield a minimum score of zero (no anxiety) and a maximum score of twenty-one (daily anxiety). An additional item was added to assess if anxiety impacts daily activities and sociability.	Baseline, 6-Week Reassessment, and One-Year Reassessment
Other	Sleep Efficacy Scale (SES)	Assessment of patients level of confidence in being able to implement behaviors that are helpful in promoting sleep. There are nine items that are scored on a four-point scale ranging from one (not confident) to five (very confident), with a minimum score of nine, indicating lower self-efficacy, and a maximum score of forty-five indicating higher self-efficacy.	Baseline, 6-Week Reassessment, and One-Year Reassessment
Other	Florbetapir PET Imaging	2D imaging technique utilized to assess change in Beta Amyloid deposition in the brain over time.Interested brain areas include the frontal lobes, anterior cingulate, posterior cingulate, parietal lobes and temporal lobes.	Baseline and One-Year Assessment
Other	Magnetic Resonance Imaging (MRI)	3D imaging technique utilized to assess change in Beta Amyloid deposition in the brain over time. Interested brain areas include the frontal lobes, anterior cingulate, posterior cingulate, parietal lobes and temporal lobes.	Baseline and One-Year Assessment
Other	Motivation to Change Sleep Behaviors	Participants self-reported desire to change their current sleep behaviors. Participants will answer one item based on a five-point Likert scale ranging from zero (not at all motivated) to four (very motivated). A minimum score of zero can be obtained indicating no motivation to change sleep behaviors and a maximum score of five indicating high motivation to change sleep behaviors.	Baseline
Other	Mini Mental-State Examination (MMSE)	Assessment of mild cognitive impairment. Participants are required to answer, or complete, eleven items. For this study, participants with a score of greater than, or equal to twenty-five will be considered mildly cognitively impaired and will be excluded from the study.	Second Pre-Screening
Other	Logarithmic Near Visual Acuity Chart	Assessment of near visual acuity based on a standardized vision chart placed sixteen inches away from the participant's eyes.	Second Pre-Screening
Other	Apolipoprotein E (APOE) 4 Genotyping	A blood draw of twenty milliliters utilized to determine if a participant may have probable late onset Alzheimer's disease.	Baseline
Other	Coin in Hand	Assessment of the participants effort to ensure full effort is being given during testing.	Baseline, 6-Week Reassessment, and One-Year Reassessment
Other	Grooved Pegboard Test	Assessment of the participants speed at completing a task requiring fine motor skills. Outcome is the amount of time required for the participant to place twenty-five pegs into the pegboard first utilizing their dominant hand only, then using their non-dominant hand only.	Baseline, 6-Week Reassessment, and One-Year Reassessment
Primary	Continuous Performance Test (CPT)	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.	Baseline, 6-Week Reassessment, and One-Year Reassessment
Primary	Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	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.	Baseline, 6-Week Reassessment, and One-Year Reassessment
Primary	Stroop Test	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.	Baseline, 6-Week Reassessment, and One-Year Reassessment
Primary	Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test	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.	Baseline, 6-Week Reassessment, and One-Year Reassessment
Secondary	Polysomnography	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.	Second Pre-Screening/Baseline, 6-Week Reassessment, and One-Year Assessment