NCT03954210Completed
SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 13 May 2019
- Start date
- 27 Aug 2019
- Primary completion date
- 18 Apr 2025
- Lead sponsor
- University of Kansas Medical Center
- Diseases
- Alzheimer disease
- NCT number
- NCT03954210
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 27 Aug 2019 to the primary completion date, 18 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking benzodiazepines, non-benzodiazepines, melatonin supplements, or agonists for insomnia
- Currently receiving CBT-I treatment
Other illness
- A known untreated sleep disorder (i.e., sleep apnea or restless leg syndrome)
- 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
- Failure of a near vision test utilizing the Logarithmic Near Visual Acuity Chart
Other
- 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)
- Unable to hear at a conversational level
Who the study is looking for
- 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)
Age in the registry: 60 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kansas Medical Center- Sleep, Health and Wellness Laboratory Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
Related publications
- The impact of cognitive behavioral therapy for insomnia on cognitive performance and amyloid beta in older adults: A randomized controlled trial.Alzheimers Dement · 2026 · PMID 42298279
This page is information, not medical advice. Discuss any trial with your doctor.