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

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ClinicalTrials.gov Identifier: NCT03954210
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date July 2, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Change in Continuous Performance Test (CPT) [ Time Frame: 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.
  • Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: 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.
  • Change in Stroop Test [ Time Frame: 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.
  • Grooved Pegboard Test [ Time Frame: Baseline ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03954210 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
Change in Polysomnography [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 15, 2019)
  • Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: Pre-Screening/Baseline, 6-Week Reassessment and One-Year Reassessment ]
    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.
  • Change in Generalized Anxiety Disorder Assessment (GAD-7) [ Time Frame: Baseline, 6-Week Reassessment, and One-Year Reassessment ]
    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.
  • Change in Sleep Efficacy Scale (SES) [ Time Frame: Baseline, 6-Week Reassessment, and One-Year Reassessment ]
    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.
  • Motivation to Change Sleep Behaviors [ Time Frame: Baseline ]
    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.
  • Florbetapir PET Imaging [ Time Frame: Baseline and One-Year Assessment ]
    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.
  • Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and One-Year Assessment ]
    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.
  • Mini Mental-State Examination (MMSE) [ Time Frame: Second Pre-Screening ]
    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.
  • Logarithmic Near Visual Acuity Chart [ Time Frame: Second Pre-Screening ]
    Assessment of near visual acuity based on a standardized vision chart placed sixteen inches away from the participant's eyes.
  • Apolipoprotein E (APOE) 4 Genotyping [ Time Frame: Baseline ]
    A blood draw of twenty milliliters utilized to determine if a participant may have probable late onset Alzheimer's disease.
  • Coin in Hand Test [ Time Frame: Baseline ]
    Assessment of the participants effort to ensure full effort is being given during testing. Participants will be required to guess the correct hand the examiner has placed a coin in after the examiner has showed them the coin and counting backwards from ten. Effort is determined by the number of correct trials the participant obtains out of ten, with malingering participants performing at chance level.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
Official Title  ICMJE SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
Brief Summary The objective of this study is to compare the efficacy of Cognitive Behavioral Training for Insomnia (CBT-I) 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 to examine the efficacy of CBT-I on reducing the rate of Aβ deposition. Participants, ages 60-85, will be randomly assigned to a six-week CBT-I training or to an active control group. A sub-group of fifty CBT-I participants will undergo Florbetapir-Positron-emission tomography (PET) imaging during the one-year reassessment to examine the efficacy of CBT-I on reducing the rate of Aβ accumulation from baseline to one year post CBT-I.
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. CBT-I is an efficacious treatment for insomnia, but the use of CBT-I to improve cognitive function and potentially reduce the rate of Aβ accumulation has never been examined. Therefore, the long-term goal of this research agenda is to understand how addressing sleep disturbances may delay the onset of AD.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Masking Description:
Both the primary investigator and the research assistant will be blinded to the participant's intervention group.
Primary Purpose: Prevention
Condition  ICMJE Insomnia
Intervention  ICMJE
  • 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.
  • Behavioral: Active Control
    Participants in the active control 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.
Study Arms  ICMJE
  • Experimental: 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.

    Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
  • Active Comparator: Six-Week Active Control

    Active Control, six sessions, forty-five to sixty minutes in duration.

    Sessions will include: stretching and thinking activities (i.e., playing board games, puzzle games, or Nintendo Wii).

    Intervention: Behavioral: Active Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, or has received, CBT-I treatment
  • Unable to hear at a conversational level
  • Failure of a near vision test utilizing the Logarithmic Near Visual Acuity Chart
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Eryen Nelson, MPH (913) 585-7349 enelson5@kumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954210
Other Study ID Numbers  ICMJE IRB # STUDY00143545
R01AG058530 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Catherine Siengsukon, PT, PhD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP