N/A
Completed N=200
SIESTA: Sleep Intervention to Enhance Cognitive Status and Reduce Beta Amyloid
Insomnia
Source: ClinicalTrials.gov NCT03954210 ↗
Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Continuous Performance Test (CPT) — 56.2; 55.8 T-Score
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Performance Test (CPT) |
56.2; 55.8 | — |
| PRIMARY Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) |
108.7; 111.2 | — |
| PRIMARY Stroop Test |
-.7; 1.1 | — |
| PRIMARY Neuropsychological Assessment Battery-Digits Forward/Digits Backward Test |
6.9; 6.8; 5.1; 5 | — |
| SECONDARY Polysomnography |
57.0; 60.3; 192; 209; 319.5; 337.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03954210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.