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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG058530 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Six-Week CBT-I Program | Experimental | 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. |
|
| Six-Week Sleep and Lifestyle Education Program | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. Hit Reaction Time (HRT) is reported as a T-score (M = 50, SD = 10), where higher scores indicate slower reaction time and worse performance. | 6-Week Reassessment |
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Cognitive function will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS consists of 12 subtests assessing immediate memory, visuospatial/constructional abilities, language, attention, and delayed memory. The RBANS Total Scale Score is reported as a Standard Score with a normative mean of 100 and standard deviation of 15. Possible scores range from 40 to 160. Higher scores indicate better overall cognitive performance. | 6-Week Reassessment |
| 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. Stroop Interference outcomes were reported as T-scores (M = 50, SD = 10), with higher scores reflecting greater interference and worse executive function. | 6-Week Reassessment |
| Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test | Participants are asked to recall strings of numbers in order (Forward) and in reverse order (Backward). The outcome is the longest string of numbers correctly recalled in each direction. Scores are reported as Standard Scores (M = 10, SD = 3), with possible scores ranging from 1 to 19. Higher scores indicate better auditory attention, immediate memory (Forward), and working memory/executive function (Backward). |
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography | Sleep measures were evaluated using one overnight polysomnography (PSG). Standardized protocols were used to prepare the participants and place six electroencephalogram sensors to detect brain wave activity. Total sleep time (TST), time in bed (TIB), wake after sleep onset (WASO), sleep onset latency (SOL), sleep stages 1 (N1), 2 (N2), and 3 (N3), and rapid eye movement sleep (REM) were determined using standardized scoring procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Siengsukon, PT, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center- Sleep, Health and Wellness Laboratory | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24605807 | Background | Solomon A, Mangialasche F, Richard E, Andrieu S, Bennett DA, Breteler M, Fratiglioni L, Hooshmand B, Khachaturian AS, Schneider LS, Skoog I, Kivipelto M. Advances in the prevention of Alzheimer's disease and dementia. J Intern Med. 2014 Mar;275(3):229-50. doi: 10.1111/joim.12178. | |
| 26836177 | Background | Wang J, Tan L, Yu JT. Prevention Trials in Alzheimer's Disease: Current Status and Future Perspectives. J Alzheimers Dis. 2016;50(4):927-45. doi: 10.3233/JAD-150826. |
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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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Everyone who was enrolled in study was randomized into CBT-I or active control.
All study assessments took place at the University of Kansas Medical Center (KUMC) from August 2019 to April 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Six-Week Sleep and Lifestyle Education Program | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Individuals were eligible to participate if between 60 and 85 years of age, cognitively normal, reporting symptoms of insomnia (i.e., difficulty falling asleep, maintaining sleep, or waking up too early at least three times a week for three consecutive months), and scoring 10 or greater on the Insomnia Severity Index (ISI).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. Hit Reaction Time (HRT) is reported as a T-score (M = 50, SD = 10), where higher scores indicate slower reaction time and worse performance. | Posted | Mean | Standard Deviation | T-Score | 6-Week Reassessment |
|
1 year
The definitions do not differ from clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction to PSG gel | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant reported hives on face and chest after placement of PSG sensors using gel/glue. Resolved without serious intervention. |
The study is limited in that it is a pilot study with the primary focus of generating effect sizes to inform powering future studies. Additionally, PSG was only performed one night; those outcomes may be influenced by the first night effect. The generalizability of our findings may be limited due to the sample. Since the subsample of Aβ analysis was voluntary, there may be selection bias in that sample.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine Siengsukon | University of Kansas Medical Center | 913-588-6913 | csiengsukon@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2022 | Dec 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D012890 | Sleep |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D009424 | Nervous System Physiological Phenomena |
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The research assistant will be blinded to the participant's intervention group.
|
| Sleep and Lifestyle Education | Behavioral | 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. |
|
| 6-Week Reassessment |
| 6-Week Reassessment |
| 6-Week Reassessment |
| 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. GAD-7 outcomes were reported as total scores ranging from 0 to 21, calculated by summing the seven individual item scores. Higher scores reflect greater anxiety severity and worse outcomes. | 6-Week Reassessment |
| 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. | 6-Week Reassessment |
| Florbetapir PET Imaging | Change in global cortical beta amyloid deposition over time will be assessed using Florbetapir PET imaging. Cortical regions of interest, including the frontal lobes, anterior cingulate, posterior cingulate, parietal lobes, and temporal lobes, were combined to compute a single global cortical Centiloid score. Scores are reported on the Centiloid scale, with values ranging from 0 to 100. Higher scores indicate greater beta amyloid deposition. | One-Year Assessment |
| Magnetic Resonance Imaging (MRI) | Cortical beta amyloid deposition was assessed using MRI spatially aligned with Florbetapir PET imaging. Cortical regions of interest were analyzed to derive the Beta Amyloid Centiloid Score. Scores range from 0 to 100, with higher scores indicating greater beta amyloid deposition. This outcome mirrors the Centiloid score obtained from the Florbetapir PET outcome. | One-Year Assessment |
| Motivation to Change Sleep Behaviors | Participants self-reported their motivation to change sleep behaviors using a single item rated on a five-point Likert scale from 0 (not at all motivated) to 4 (very motivated). Higher scores reflect greater motivation to change sleep behaviors, with a minimum possible score of 0 and a maximum of 4. | Baseline |
| Mini Mental-State Examination (MMSE) | Cognitive function was assessed using the Mini-Mental State Examination (MMSE). Participants completed 11 items assessing orientation, registration, attention and calculation, recall, language, and visuospatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Participants with scores ≥25 were excluded from the study. The outcome was assessed at baseline. | Baseline |
| Logarithmic Near Visual Acuity Chart | Participants completed a brief vision screening to assess basic visual acuity and function. Higher scores indicate better visual performance. The outcome was assessed at baseline. | Baseline |
| Apolipoprotein E (APOE) 4 Genotyping | Participants' APOE genotype was determined via blood draw using standard genotyping methods. Participants were classified as E4-negative (no e4 allele) or E4-positive (at least one e4 allele). E4-positive participants are considered to have a higher genetic risk for Alzheimer's disease. Counts of participants are reported for each category, with the sum of both categories equal to the total number of participants analyzed in each study arm. | Baseline |
| Coin in Hand | The Coin in Hand Assessment is a brief test of participant effort and motivation. On each trial, the examiner shows a coin in one of two hands for ~2 seconds. The participant then closes their eyes, counts backward from 10, and indicates which hand held the coin. Ten trials are administered, with the coin equally distributed between hands in random order. The outcome measure is the total number of correct responses, with higher scores indicating better attention and effort. | 6-Week Reassessment |
| Grooved Pegboard Test | Fine motor coordination and manual dexterity will be assessed using the Grooved Pegboard Test. Participants are asked to place pegs into the pegboard as quickly as possible. The primary outcome is the time required to complete the task. Scores are reported as mean ± standard deviation. Higher values indicate slower performance. | 6-Week Reassessment |
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| 42298279 | Derived | Siengsukon CF, Hand LK, Nelson E, Glaser A, Ludwig R, Russell JA, Phadnis MA, Dai J, Bruce J, Vidoni ED, Drerup M, Morris J, Burns JM. The impact of cognitive behavioral therapy for insomnia on cognitive performance and amyloid beta in older adults: A randomized controlled trial. Alzheimers Dement. 2026 Jun;22(6):e71591. doi: 10.1002/alz.71591. |
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| BG001 | Six-Week Sleep and Lifestyle Education Program | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | No |
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| OG001 | Six-Week Sleep and Lifestyle Education Program | 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. 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. |
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| Primary | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Cognitive function will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS consists of 12 subtests assessing immediate memory, visuospatial/constructional abilities, language, attention, and delayed memory. The RBANS Total Scale Score is reported as a Standard Score with a normative mean of 100 and standard deviation of 15. Possible scores range from 40 to 160. Higher scores indicate better overall cognitive performance. | Not all enrolled participants completed the RBANS assessment. The Overall Number of Participants Analyzed reflects those who completed the assessment: 95 in the CBT-I group and 89 in the control group. Reasons for missing assessments included participant withdrawal, scheduling conflicts, and incomplete data collection. | Posted | Mean | Standard Deviation | Score on a scale | 6-Week Reassessment |
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| 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. Stroop Interference outcomes were reported as T-scores (M = 50, SD = 10), with higher scores reflecting greater interference and worse executive function. | Posted | Mean | Standard Deviation | Interference T-Score | 6-Week Reassessment |
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| Primary | Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test | Participants are asked to recall strings of numbers in order (Forward) and in reverse order (Backward). The outcome is the longest string of numbers correctly recalled in each direction. Scores are reported as Standard Scores (M = 10, SD = 3), with possible scores ranging from 1 to 19. Higher scores indicate better auditory attention, immediate memory (Forward), and working memory/executive function (Backward). | Posted | Mean | Standard Deviation | Digits | 6-Week Reassessment |
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| Secondary | Polysomnography | Sleep measures were evaluated using one overnight polysomnography (PSG). Standardized protocols were used to prepare the participants and place six electroencephalogram sensors to detect brain wave activity. Total sleep time (TST), time in bed (TIB), wake after sleep onset (WASO), sleep onset latency (SOL), sleep stages 1 (N1), 2 (N2), and 3 (N3), and rapid eye movement sleep (REM) were determined using standardized scoring procedures. | Posted | Mean | Standard Deviation | Minutes | 6-Week Reassessment |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Total Score | 6-Week Reassessment |
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| Other Pre-specified | 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. GAD-7 outcomes were reported as total scores ranging from 0 to 21, calculated by summing the seven individual item scores. Higher scores reflect greater anxiety severity and worse outcomes. | Posted | Mean | Standard Deviation | Total Score | 6-Week Reassessment |
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| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | Total Score | 6-Week Reassessment |
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| Other Pre-specified | Florbetapir PET Imaging | Change in global cortical beta amyloid deposition over time will be assessed using Florbetapir PET imaging. Cortical regions of interest, including the frontal lobes, anterior cingulate, posterior cingulate, parietal lobes, and temporal lobes, were combined to compute a single global cortical Centiloid score. Scores are reported on the Centiloid scale, with values ranging from 0 to 100. Higher scores indicate greater beta amyloid deposition. | Not all enrolled participants completed the PET imaging assessment. The Overall Number of Participants Analyzed reflects those who completed the assessment: 18 in the CBT-I group and 19 in the control group. Reasons for missing assessments included participant withdrawal, scheduling conflicts, and incomplete data collection. | Posted | Mean | Standard Deviation | Score on a scale | One-Year Assessment |
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| Other Pre-specified | Magnetic Resonance Imaging (MRI) | Cortical beta amyloid deposition was assessed using MRI spatially aligned with Florbetapir PET imaging. Cortical regions of interest were analyzed to derive the Beta Amyloid Centiloid Score. Scores range from 0 to 100, with higher scores indicating greater beta amyloid deposition. This outcome mirrors the Centiloid score obtained from the Florbetapir PET outcome. | Posted | Mean | Standard Deviation | Score on a scale | One-Year Assessment |
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| Other Pre-specified | Motivation to Change Sleep Behaviors | Participants self-reported their motivation to change sleep behaviors using a single item rated on a five-point Likert scale from 0 (not at all motivated) to 4 (very motivated). Higher scores reflect greater motivation to change sleep behaviors, with a minimum possible score of 0 and a maximum of 4. | Posted | Mean | Standard Deviation | Total Score | Baseline |
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| Other Pre-specified | Mini Mental-State Examination (MMSE) | Cognitive function was assessed using the Mini-Mental State Examination (MMSE). Participants completed 11 items assessing orientation, registration, attention and calculation, recall, language, and visuospatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Participants with scores ≥25 were excluded from the study. The outcome was assessed at baseline. | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
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| Other Pre-specified | Logarithmic Near Visual Acuity Chart | Participants completed a brief vision screening to assess basic visual acuity and function. Higher scores indicate better visual performance. The outcome was assessed at baseline. | Posted | Mean | Standard Deviation | Number of Correct Responses | Baseline |
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| Other Pre-specified | Apolipoprotein E (APOE) 4 Genotyping | Participants' APOE genotype was determined via blood draw using standard genotyping methods. Participants were classified as E4-negative (no e4 allele) or E4-positive (at least one e4 allele). E4-positive participants are considered to have a higher genetic risk for Alzheimer's disease. Counts of participants are reported for each category, with the sum of both categories equal to the total number of participants analyzed in each study arm. | Posted | Number | participants | Baseline |
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| Other Pre-specified | Coin in Hand | The Coin in Hand Assessment is a brief test of participant effort and motivation. On each trial, the examiner shows a coin in one of two hands for ~2 seconds. The participant then closes their eyes, counts backward from 10, and indicates which hand held the coin. Ten trials are administered, with the coin equally distributed between hands in random order. The outcome measure is the total number of correct responses, with higher scores indicating better attention and effort. | Posted | Mean | Standard Deviation | Number of Correct Responses | 6-Week Reassessment |
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| Other Pre-specified | Grooved Pegboard Test | Fine motor coordination and manual dexterity will be assessed using the Grooved Pegboard Test. Participants are asked to place pegs into the pegboard as quickly as possible. The primary outcome is the time required to complete the task. Scores are reported as mean ± standard deviation. Higher values indicate slower performance. | Posted | Mean | Standard Deviation | Minutes | 6-Week Reassessment |
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| 0 |
| 100 |
| 0 |
| 100 |
| 1 |
| 100 |
| EG001 | Six-Week Sleep and Lifestyle Education Program | 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. 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. | 0 | 100 | 0 | 100 | 1 | 100 |
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| Discomfort / aura / headache during CPT | Nervous system disorders | Non-systematic Assessment | During baseline CPT, participant experienced a transient white visual aura. Followed by a headache that resolved with OTC pain reliever at home. |
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Not provided
Not provided
| D001523 |
| Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Total Sleep Time |
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| Time in Bed |
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| Wake After Sleep Onset |
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| Sleep Onset Latency |
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| N1 Sleep |
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| N3 Sleep |
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