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New sleep therapy aims to help veterans with memory loss get better rest

NCT ID NCT05016960

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This pilot study tested a program called Sleep-SMART for veterans aged 60 and older who have both mild cognitive impairment (MCI) and insomnia. The program combines standard insomnia therapy with memory-support strategies to help participants learn and stick with the treatment. Researchers measured how satisfied and engaged the 30 veterans were with the telehealth-delivered program.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sleep-SMART (behavioral therapy combining Cognitive Behavioral Therapy for Insomnia with cognitive strategies)
What this could lead to
If successful, this approach could help older veterans with memory problems get better sleep and potentially improve their daily functioning and quality of life.
What could go wrong
This is a very small pilot study with only 30 participants, so results may not apply to everyone. The study is also focused on feasibility, not on proving the treatment works.

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

30 people

The number who actually took part.

Started

Jan 2022

Finished

Dec 2023

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 ages 60 or older who are competent to provide informed consent * Chart diagnosis of MCI based on previously published criteria * 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 Exclusion Criteria: * Sleep disorders other than insomnia as determined by medical chart review and clinical interview * History of a neurological disorder, dementia, or moderate to severe TBI * Auditory, visual, or other impairments that would prevent ability to use video teleconferencing or participate in assessments * Schizophrenia, psychotic disorder, bipolar disorder, and/or current substance use disorder * Suicidality more than "low risk" as assessed by the Columbia Suicide Severity Rating Scale

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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

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.