Insomnia
Conditions
Keywords
Cognitive Behavioral Therapy for Insomnia, CBT-I, Alzheimer's, Alzheimer's Disease
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.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALSleep 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.
Sponsors
University of Kansas Medical Center
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
The research assistant will be blinded to the participant's intervention group.
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Performance Test (CPT) | 6-Week 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. Hit Reaction Time (HRT) is reported as a T-score (M = 50, SD = 10), where higher scores indicate slower reaction time and worse performance. |
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | 6-Week Reassessment | 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. |
| Stroop Test | 6-Week 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. Stroop Interference outcomes were reported as T-scores (M = 50, SD = 10), with higher scores reflecting greater interference and worse executive function. |
| Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test | 6-Week Reassessment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polysomnography | 6-Week Reassessment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCatherine Siengsukon, PT, PhD
University of Kansas Medical Center
Participant flow
Recruitment details
All study assessments took place at the University of Kansas Medical Center (KUMC) from August 2019 to April 2025.
Pre-assignment details
Everyone who was enrolled in study was randomized into CBT-I or active control.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 72 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age, Continuous | 69.4 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 174 Participants |
| Region of Enrollment United States | 200 Participants |
| Sex: Female, Male Female | 158 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 1 / 100 | 1 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
None listed