NCT03954210 · COMPLETED
SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
This trial is testing whether Cognitive Behavioral Therapy for Insomnia (CBT-I) — a structured, talk-based sleep program — can improve memory and thinking skills in older adults with chronic insomnia, and whether it can slow the buildup of amyloid protein in the brain. Some participants will get a brain PET scan to measure that amyloid change. This is a Phase NA (non-drug) trial, meaning it is evaluating a behavioral program, not a medication.
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're excluded 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-27