InsomniaNCT03954210
SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Sleep and Lifestyle Education in people with Insomnia, run by University of Kansas Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-I) and Sleep and Lifestyle Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2019to 18 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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 and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
Kansas City, Kansas, 66160
About this study
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I), Sleep and Lifestyle Education
- Keywords
- Cognitive Behavioral Therapy for Insomnia, CBT-I, Alzheimer's, Alzheimer's Disease
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
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.
Sleep and Lifestyle EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| 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. Receives: Behavioral: Sleep and Lifestyle Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6-Week Reassessment
Secondary outcomes (1)
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.
Measured: 6-Week Reassessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start27 Aug 2019
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Catherine Siengsukon, PT, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954210
- Sponsor's protocol ID
- STUDY00143545
- Other IDs
- R01AG058530
- Status last verified
- Mar 2026
- First submitted
- 13 May 2019
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 24605807Wang 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.
PubMed 26836177Bubu OM, Brannick M, Mortimer J, Umasabor-Bubu O, Sebastiao YV, Wen Y, Schwartz S, Borenstein AR, Wu Y, Morgan D, Anderson WM. Sleep, Cognitive impairment, and Alzheimer's disease: A Systematic Review and Meta-Analysis. Sleep. 2017 Jan 1;40(1). doi: 10.1093/sleep/zsw032.
PubMed 28364458Alessi C, Vitiello MV. Insomnia (primary) in older people: non-drug treatments. BMJ Clin Evid. 2015 May 13;2015:2302.
PubMed 25968443Lobo A, Lopez-Anton R, de-la-Camara C, Quintanilla MA, Campayo A, Saz P; ZARADEMP Workgroup. Non-cognitive psychopathological symptoms associated with incident mild cognitive impairment and dementia, Alzheimer's type. Neurotox Res. 2008 Oct;14(2-3):263-72. doi: 10.1007/BF03033815.
PubMed 19073431Osorio RS, Pirraglia E, Aguera-Ortiz LF, During EH, Sacks H, Ayappa I, Walsleben J, Mooney A, Hussain A, Glodzik L, Frangione B, Martinez-Martin P, de Leon MJ. Greater risk of Alzheimer's disease in older adults with insomnia. J Am Geriatr Soc. 2011 Mar;59(3):559-62. doi: 10.1111/j.1532-5415.2010.03288.x. No abstract available.
PubMed 21391952Cricco M, Simonsick EM, Foley DJ. The impact of insomnia on cognitive functioning in older adults. J Am Geriatr Soc. 2001 Sep;49(9):1185-9. doi: 10.1046/j.1532-5415.2001.49235.x.
PubMed 11559377Ju YE, Lucey BP, Holtzman DM. Sleep and Alzheimer disease pathology--a bidirectional relationship. Nat Rev Neurol. 2014 Feb;10(2):115-9. doi: 10.1038/nrneurol.2013.269. Epub 2013 Dec 24.
PubMed 24366271Branger P, Arenaza-Urquijo EM, Tomadesso C, Mezenge F, Andre C, de Flores R, Mutlu J, de La Sayette V, Eustache F, Chetelat G, Rauchs G. Relationships between sleep quality and brain volume, metabolism, and amyloid deposition in late adulthood. Neurobiol Aging. 2016 May;41:107-114. doi: 10.1016/j.neurobiolaging.2016.02.009. Epub 2016 Feb 17.
PubMed 27103523Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224.
PubMed 24136970Wang MY, Wang SY, Tsai PS. Cognitive behavioural therapy for primary insomnia: a systematic review. J Adv Nurs. 2005 Jun;50(5):553-64. doi: 10.1111/j.1365-2648.2005.03433.x.
PubMed 15882372Geiger-Brown JM, Rogers VE, Liu W, Ludeman EM, Downton KD, Diaz-Abad M. Cognitive behavioral therapy in persons with comorbid insomnia: A meta-analysis. Sleep Med Rev. 2015 Oct;23:54-67. doi: 10.1016/j.smrv.2014.11.007. Epub 2014 Nov 29.
PubMed 25645130Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841.
PubMed 26054060Wu JQ, Appleman ER, Salazar RD, Ong JC. Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. JAMA Intern Med. 2015 Sep;175(9):1461-72. doi: 10.1001/jamainternmed.2015.3006.
PubMed 26147487Diekelmann S, Wilhelm I, Born J. The whats and whens of sleep-dependent memory consolidation. Sleep Med Rev. 2009 Oct;13(5):309-21. doi: 10.1016/j.smrv.2008.08.002. Epub 2009 Feb 28.
PubMed 19251443
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
- ClinicalTrials.gov ID
- NCT03954210
- Acronym / sponsor ID
- STUDY00143545
- Conditions
- Insomnia
- Keywords
- Cognitive Behavioral Therapy for Insomnia, CBT-I, Alzheimer's, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Six-Week CBT-I Program | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)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 | Behavioral: Sleep and Lifestyle EducationSleep 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Six-Week CBT-I Program |
| Sleep and Lifestyle EducationParticipants 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. | Behavioural | Six-Week Sleep and Lifestyle Education Program |
Primary outcome
Continuous Performance Test (CPT)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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).
1 secondary outcome
Polysomnography
Time frame: 6-Week Reassessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24605807Solomon 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.
- Background: PubMed 26836177Wang 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.
- Background: PubMed 28364458Bubu OM, Brannick M, Mortimer J, Umasabor-Bubu O, Sebastiao YV, Wen Y, Schwartz S, Borenstein AR, Wu Y, Morgan D, Anderson WM. Sleep, Cognitive impairment, and Alzheimer's disease: A Systematic Review and Meta-Analysis. Sleep. 2017 Jan 1;40(1). doi: 10.1093/sleep/zsw032.
- Background: PubMed 25968443Alessi C, Vitiello MV. Insomnia (primary) in older people: non-drug treatments. BMJ Clin Evid. 2015 May 13;2015:2302.
- Background: PubMed 19073431Lobo A, Lopez-Anton R, de-la-Camara C, Quintanilla MA, Campayo A, Saz P; ZARADEMP Workgroup. Non-cognitive psychopathological symptoms associated with incident mild cognitive impairment and dementia, Alzheimer's type. Neurotox Res. 2008 Oct;14(2-3):263-72. doi: 10.1007/BF03033815.
- Background: PubMed 21391952Osorio RS, Pirraglia E, Aguera-Ortiz LF, During EH, Sacks H, Ayappa I, Walsleben J, Mooney A, Hussain A, Glodzik L, Frangione B, Martinez-Martin P, de Leon MJ. Greater risk of Alzheimer's disease in older adults with insomnia. J Am Geriatr Soc. 2011 Mar;59(3):559-62. doi: 10.1111/j.1532-5415.2010.03288.x. No abstract available.
- Background: PubMed 11559377Cricco M, Simonsick EM, Foley DJ. The impact of insomnia on cognitive functioning in older adults. J Am Geriatr Soc. 2001 Sep;49(9):1185-9. doi: 10.1046/j.1532-5415.2001.49235.x.
- Background: PubMed 24366271Ju YE, Lucey BP, Holtzman DM. Sleep and Alzheimer disease pathology--a bidirectional relationship. Nat Rev Neurol. 2014 Feb;10(2):115-9. doi: 10.1038/nrneurol.2013.269. Epub 2013 Dec 24.
- Background: PubMed 27103523Branger P, Arenaza-Urquijo EM, Tomadesso C, Mezenge F, Andre C, de Flores R, Mutlu J, de La Sayette V, Eustache F, Chetelat G, Rauchs G. Relationships between sleep quality and brain volume, metabolism, and amyloid deposition in late adulthood. Neurobiol Aging. 2016 May;41:107-114. doi: 10.1016/j.neurobiolaging.2016.02.009. Epub 2016 Feb 17.
- Background: PubMed 24136970Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224.
- Background: PubMed 15882372Wang MY, Wang SY, Tsai PS. Cognitive behavioural therapy for primary insomnia: a systematic review. J Adv Nurs. 2005 Jun;50(5):553-64. doi: 10.1111/j.1365-2648.2005.03433.x.
- Background: PubMed 25645130Geiger-Brown JM, Rogers VE, Liu W, Ludeman EM, Downton KD, Diaz-Abad M. Cognitive behavioral therapy in persons with comorbid insomnia: A meta-analysis. Sleep Med Rev. 2015 Oct;23:54-67. doi: 10.1016/j.smrv.2014.11.007. Epub 2014 Nov 29.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Siengsukon, PT, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Sleep and Lifestyle Education in people with Insomnia, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Performance Test (CPT) (time frame: 6-Week Reassessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03954210, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.