SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03954210|
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) Behavioral: Active Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Masking Description:||The research assistant will be blinded to the participant's intervention group.|
|Official Title:||SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid|
|Actual Study Start Date :||August 27, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
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.
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.
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).
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.
- 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.
- Change in Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test [ Time Frame: 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.
- Change in Grooved Pegboard Test [ Time Frame: Baseline, 6-Week Reassessment, and One-Year Reassessment ]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 [ Time Frame: Baseline, 6-Week Reassessment, and One-Year Reassessment ]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.
- 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.
- 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.
- Change in 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.
- Change in 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954210
|Contact: Eryen Nelson, MPH||(913) email@example.com|
|United States, Kansas|
|University of Kansas Medical Center- Sleep, Health and Wellness Laboratory||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Eryen Nelson, MPH 913-945-7349 firstname.lastname@example.org|
|Principal Investigator: Catherine Siengsukon, PT, PhD|
|Sub-Investigator: Jeff Burns, MD|
|Sub-Investigator: Eric Vidoni, PT, PhD|
|Sub-Investigator: Jonathan Mahnken, PhD|
|Principal Investigator:||Catherine Siengsukon, PT, PhD||University of Kansas Medical Center|