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New sleep therapy aims to boost brain health in veterans

NCT ID NCT07397182

Symptom relief Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests a sleep therapy called SleepSMART for older veterans who have both insomnia and mild cognitive impairment (MCI). The therapy adapts standard insomnia treatment with extra memory and learning support. Researchers will compare SleepSMART to standard therapy in 150 veterans to see which improves sleep and thinking more.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Mild cognitive impairment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161-0002, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.