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

Primary Purpose

Insomnia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Sleep and Lifestyle Education

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Cognitive Behavioral Therapy for Insomnia, CBT-I, Alzheimer's, Alzheimer's Disease

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

University of Kansas Medical Center- Sleep, Health and Wellness LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Six-Week CBT-I Program

Six-Week Sleep and Lifestyle Education Program

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in 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.

Change in 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.

Change in 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.

Change in 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.

Change in 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.

Change in Coin in Hand

Assessment of the participants effort to ensure full effort is being given during testing. Participants will be required to recall the correct hand the examiner has placed a coin in after the examiner has shown them the coin and counting backward from ten. Effort is determined by the number of correct trials the participant obtains out of ten, with malingering participants performing at chance level.

Secondary Outcome Measures

Change in 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.

Full Information

NCT ID

NCT03954210

First Posted

May 13, 2019

Last Updated

November 1, 2022

Sponsor

University of Kansas Medical Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03954210

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 27, 2019 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Kansas Medical Center

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

Cognitive Behavioral Therapy for Insomnia, CBT-I, Alzheimer's, Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Masking Description

The research assistant will be blinded to the participant's intervention group.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Six-Week CBT-I Program

Arm Type

Experimental

Arm Description

Arm Title

Six-Week Sleep and Lifestyle Education Program

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Sleep and Lifestyle Education

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Continuous Performance Test (CPT)

Description

Time Frame

Baseline, 6-Week Reassessment, and One-Year Reassessment

Title

Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Description

Time Frame

Baseline, 6-Week Reassessment, and One-Year Reassessment

Title

Change in Stroop Test

Description

Time Frame

Baseline, 6-Week Reassessment, and One-Year Reassessment

Title

Change in Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test

Description

Time Frame

Baseline, 6-Week Reassessment, and One-Year Reassessment

Title

Change in Grooved Pegboard Test

Description

Time Frame

Baseline, 6-Week Reassessment, and One-Year Reassessment

Title

Change in Coin in Hand

Description

Time Frame

Baseline, 6-Week Reassessment, and One-Year Reassessment

Secondary Outcome Measure Information:

Title

Change in Polysomnography

Description

Time Frame

Second Pre-Screening/Baseline, 6-Week Reassessment, and One-Year Assessment

Other Pre-specified Outcome Measures:

Title

Change in Patient Health Questionnaire (PHQ-9)

Description

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.

Time Frame

Pre-Screening/Baseline, 6-Week Reassessment and One-Year Reassessment

Title

Change in Generalized Anxiety Disorder Assessment (GAD-7)

Description

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.

Time Frame

Baseline, 6-Week Reassessment, and One-Year Reassessment

Title

Change in Sleep Efficacy Scale (SES)

Description

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.

Time Frame

Baseline, 6-Week Reassessment, and One-Year Reassessment

Title

Change in Florbetapir PET Imaging

Description

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.

Time Frame

Baseline and One-Year Assessment

Title

Change in Magnetic Resonance Imaging (MRI)

Description

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.

Time Frame

Baseline and One-Year Assessment

Title

Motivation to Change Sleep Behaviors

Description

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.

Time Frame

Baseline

Title

Mini Mental-State Examination (MMSE)

Description

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.

Time Frame

Second Pre-Screening

Title

Logarithmic Near Visual Acuity Chart

Description

Assessment of near visual acuity based on a standardized vision chart placed sixteen inches away from the participant's eyes.

Time Frame

Second Pre-Screening

Title

Apolipoprotein E (APOE) 4 Genotyping

Description

A blood draw of twenty milliliters utilized to determine if a participant may have probable late onset Alzheimer's disease.

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eryen Nelson, MPH

Phone

(913) 945-7349

enelson5@kumc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine Siengsukon, PT, PhD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center- Sleep, Health and Wellness Laboratory

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eryen Nelson, MPH

Phone

913-945-7349

enelson5@kumc.edu

First Name & Middle Initial & Last Name & Degree

Catherine Siengsukon, PT, PhD

First Name & Middle Initial & Last Name & Degree

Jeff Burns, MD

First Name & Middle Initial & Last Name & Degree

Eric Vidoni, PT, PhD

First Name & Middle Initial & Last Name & Degree

Jonathan Mahnken, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No individual participant data will be made available to other researchers. However, the results of this study will be registered to ClinicalTrials.gov within twelve months of the primary study completion date including information about participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol, and statistical analysis plan, and administrative information. In addition, results will be disseminated via oral presentations and news stories in collaboration with the University of Kansas Medical Center public relations team and local news outlets.

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

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