SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
New study tests sleep therapy to improve thinking and reduce brain plaque in older adults.
Plain English Summary
SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid is a Not Applicable clinical trial sponsored by University of Kansas Medical Center studying Insomnia. This trial tests if a six-week sleep program can improve thinking skills and reduce a protein called beta-amyloid in older adults with insomnia. It is for adults aged 60-85 who have trouble sleeping at least three nights a week and score high on insomnia and cognitive tests. Participants will be randomly assigned to either a special sleep therapy program or a general sleep education program. Alternatives include standard insomnia treatments like medication or other forms of therapy, but this study focuses on a specific behavioral approach. The trial aims to enroll 200 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 60 and 85 years old and have had trouble sleeping for at least six months. You need to have a certain level of difficulty with sleep and a good score on a general cognitive test, with no signs of significant memory loss. You cannot join if you have another untreated sleep disorder, are currently taking certain sleep medications, have severe depression, or have a history of drug/alcohol abuse. Individuals with serious mental health conditions, nervous system disorders, or learning disabilities may also not be eligible. This trial is studying Insomnia, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how well participants' thinking skills, such as attention and memory, improve after the sleep intervention. The specific primary outcome measures are: Continuous Performance Test (CPT) (6-Week Reassessment); Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (6-Week Reassessment); Stroop Test (6-Week Reassessment); Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test (6-Week Reassessment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it explores if improving sleep can not only boost cognitive function but also potentially slow down the buildup of beta-amyloid, a protein linked to Alzheimer's disease This research targets Insomnia, where improved treatment options are needed.
Investor Insight
This trial signals potential for non-pharmacological treatments for cognitive decline and Alzheimer's prevention, a large and growing market, with a high probability of success if sleep intervention p
Is This Trial Right for Me?
Ask your doctor if this sleep intervention is right for you, especially if you have trouble sleeping or are concerned about your memory. Participation involves attending weekly sessions for six weeks, keeping a sleep diary, and potentially undergoing brain imaging (PET scan) for a subset of participants. You will be monitored for changes in your sleep, thinking abilities, and brain health over a one-year period. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 200 participants
Interventions
- 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: 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.
Primary Outcomes
- Continuous Performance Test (CPT) (6-Week Reassessment)
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (6-Week Reassessment)
- Stroop Test (6-Week Reassessment)
- Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test (6-Week Reassessment)
Secondary Outcomes
- Polysomnography (6-Week Reassessment)
Full 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
Trial Locations
- University of Kansas Medical Center- Sleep, Health and Wellness Laboratory, Kansas City, Kansas, United States
Frequently Asked Questions
What is clinical trial NCT03954210?
NCT03954210 is a Not Applicable INTERVENTIONAL study titled "SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid." It is currently completed and is sponsored by University of Kansas Medical Center. The trial targets enrollment of 200 participants.
What conditions does NCT03954210 study?
This trial investigates treatments for Insomnia. The primary condition under study is Insomnia.
What treatments are being tested in NCT03954210?
The interventions being studied include: Cognitive Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL), Sleep and Lifestyle Education (BEHAVIORAL). 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.
What does Not Applicable mean for NCT03954210?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT03954210?
This trial is currently "Completed." It started on 2019-08-27. The estimated completion date is 2025-04-18.
Who is sponsoring NCT03954210?
NCT03954210 is sponsored by University of Kansas Medical Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT03954210?
The trial aims to enroll 200 participants. The trial status is completed.
How is NCT03954210 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT03954210?
The primary outcome measures are: Continuous Performance Test (CPT) (6-Week Reassessment); Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (6-Week Reassessment); Stroop Test (6-Week Reassessment); Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test (6-Week Reassessment). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT03954210 being conducted?
This trial is being conducted at 1 site, including Kansas City, Kansas (United States).
Where can I find official information about NCT03954210?
The official record for NCT03954210 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT03954210. This government database provides the most up-to-date and detailed information about the trial.
What is NCT03954210 testing in simple terms?
This trial tests if a six-week sleep program can improve thinking skills and reduce a protein called beta-amyloid in older adults with insomnia. It is for adults aged 60-85 who have trouble sleeping at least three nights a week and score high on insomnia and cognitive tests.
Why is this trial significant?
This trial is important because it explores if improving sleep can not only boost cognitive function but also potentially slow down the buildup of beta-amyloid, a protein linked to Alzheimer's disease
What are the potential risks of participating in NCT03954210?
Potential side effects are generally mild and related to the behavioral nature of the intervention, such as temporary fatigue or frustration. Risks include the possibility that the intervention may not be effective for everyone, or that participants might experience temporary discomfort discussing sleep issues. For those undergoing PET scans, there are minimal risks associated with radiation exposure, which will be carefully managed. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT03954210?
Ask your doctor if this sleep intervention is right for you, especially if you have trouble sleeping or are concerned about your memory. Participation involves attending weekly sessions for six weeks, keeping a sleep diary, and potentially undergoing brain imaging (PET scan) for a subset of participants. You will be monitored for changes in your sleep, thinking abilities, and brain health over a one-year period. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT03954210 signal from an investment perspective?
This trial signals potential for non-pharmacological treatments for cognitive decline and Alzheimer's prevention, a large and growing market, with a high probability of success if sleep intervention p This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to either a special sleep therapy program or a general sleep education program. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.