SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid

NCT03954210 | Completed Results DMC

• 2 other identifiers: STUDY00143545R01AG058530
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Cognitive Behavioral Therapy for Insomnia; CBT-I; Alzheimer's; Alzheimer's Disease

Outcome Measures

Primary Outcomes (4)

• 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).

  6-Week Reassessment

Secondary Outcomes (1)

• Polysomnography

  6-Week Reassessment

Other Outcomes (11)

• Patient Health Questionnaire (PHQ-9)

  6-Week Reassessment

• Generalized Anxiety Disorder Assessment (GAD-7)

  6-Week Reassessment

• Sleep Efficacy Scale (SES)

  6-Week Reassessment

Study Arms (2)

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.

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.

Behavioral: Sleep and Lifestyle Education

Interventions

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.

Six-Week CBT-I Program

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.

Six-Week Sleep and Lifestyle Education Program

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• National Institutes of Health (NIH): collaborator
• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center- Sleep, Health and Wellness Laboratory

Kansas City, Kansas, 66160, United States

Location

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Alzheimer Disease

Interventions

Cognitive Behavioral Therapy; Sleep

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Catherine Siengsukon
• Organization: University of Kansas Medical Center

csiengsukon@kumc.edu

913-588-6913

Study Officials

• Catherine Siengsukon, PT, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The research assistant will be blinded to the participant's intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 17, 2019
• Study Start: August 27, 2019
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)