NCT07397182 · NOT YET RECRUITING
SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment
This trial is testing a specialized form of talk therapy for sleep called SleepSMART against standard Cognitive Behavioral Therapy for Insomnia (CBT-I) in older Veterans who have both insomnia and mild cognitive impairment. SleepSMART adds extra memory and learning support to standard CBT-I to help people with cognitive difficulties follow through with treatment. This is a randomized controlled trial — the most rigorous design for comparing two active treatments, though no drug is involved.
You may qualify if
- Veterans
- chart diagnosis MCI
- DSM-5 diagnosis of insomnia and an Insomnia Severity Index (ISI) score >7 at baseline
- ability to understand, speak, and read English with acceptable visual and auditory acuity
- stable on medications for at least 4 weeks prior to enrollment
You're excluded if
- presence of neurological disorders such as Parkinson's disease or seizures, dementia (based on chart diagnosis or clear evidence of dementia at the baseline neuropsychological testing using DSM5 criteria for Major Neurocognitive Disorder)
- and/or history of moderate to severe TBI (determined by medical record or self-report of >30 minutes loss of consciousness)
- schizophrenia, psychotic disorder, and/or bipolar disorder
- untreated or poorly managed medical conditions that may impact sleep, including thyroid disease, nocturia, chronic respiratory or heart disease, or diabetes
- untreated obstructive sleep apnea and/or sleep disturbances other than insomnia
- current substance use disorder with \<30 days abstinence
- suicidality greater than mild risk as measured by the Columbia-Suicide Severity Rating Scale
- exposure to therapist directed (individual or group) CBT-I within the past year
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 2026-02-09