SleepSMART for Insomnia and Mild Cognitive Impairment

(SleepSMART Trial)

EA
Overseen ByErin Almklov, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called SleepSMART, designed to help Veterans with both insomnia (trouble sleeping) and mild cognitive impairment (early memory and thinking problems). The goal is to determine if SleepSMART is more effective than regular therapy for insomnia, known as CBT-I, in improving sleep and cognitive function. Veterans diagnosed with both insomnia and mild cognitive impairment might be suitable candidates for this trial. As an unphased trial, participants can contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial requires that you have been stable on your medications for at least 4 weeks before joining, so you likely won't need to stop taking them.

What prior data suggests that SleepSMART is safe for older Veterans with insomnia and cognitive impairments?

Research has shown that SleepSMART, a specialized version of Cognitive Behavioral Therapy for Insomnia (CBT-I), effectively treats Veterans with insomnia and mild memory problems. Studies have found that it significantly improves sleep issues, suggesting that SleepSMART is generally easy to use. No specific reports of negative side effects have been directly linked to SleepSMART, which reassures those considering joining the trial. SleepSMART aims to enhance traditional CBT-I by incorporating additional cognitive strategies to aid in learning and adherence to the treatment. This approach builds on a treatment already known to be safe and effective for many people.12345

Why are researchers excited about this trial?

Researchers are excited about SleepSMART because it's an innovative twist on the standard Cognitive Behavioral Therapy for Insomnia (CBT-I). Designed specifically for older veterans dealing with both insomnia and mild cognitive impairment, SleepSMART enhances traditional CBT-I by incorporating supportive cognitive strategies. This unique approach aims to not only improve sleep but also boost learning and adherence to treatment, potentially offering a more comprehensive solution for those with overlapping sleep and cognitive challenges.

What evidence suggests that SleepSMART could be an effective treatment for insomnia and mild cognitive impairment?

Research has shown that SleepSMART, a treatment in this trial, yields promising results for improving sleep problems in Veterans with mild memory issues. In an initial study, participants using SleepSMART experienced significantly better sleep quality. This treatment modifies Cognitive Behavioral Therapy for Insomnia (CBT-I), the other treatment arm in this trial, by incorporating strategies to help individuals learn and adhere to the treatment. SleepSMART is specifically designed for older Veterans, offering a personalized approach for those facing both sleep and memory challenges. These early findings suggest that SleepSMART could effectively manage insomnia in this group.12367

Who Is on the Research Team?

EA

Erin Almklov, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for older veterans who have trouble sleeping (insomnia) and are also experiencing mild cognitive impairment. Participants should be able to engage in therapy sessions and adhere to treatment guidelines.

Inclusion Criteria

Veterans
Ability to understand, speak, and read English with acceptable visual and auditory acuity
Stable on medications for at least 4 weeks prior to enrollment
See 2 more

Exclusion Criteria

I have a neurological disorder like Parkinson's or seizures.
History of moderate to severe TBI (determined by medical record or self-report of >30 minutes loss of consciousness)
I have been diagnosed with schizophrenia, a psychotic disorder, or bipolar disorder.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SleepSMART or standard CBT-I for insomnia and MCI

8 weeks
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • SleepSMART

Trial Overview

The study tests SleepSMART, an adapted Cognitive Behavioral Therapy for Insomnia (CBT-I), against standard CBT-I. It aims to see if SleepSMART can better help those with insomnia and mild cognitive issues by adding supportive strategies.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: SleepSMARTExperimental Treatment1 Intervention
Group II: CBT-IActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

SleepSMART for Veterans With Insomnia and Mild ...

This proposed investigation aims to conduct a randomized controlled trial investigating the effectiveness of SleepSMART, compared to standard CBT-I in older ...

0387 Sleep-SMART for Veterans with Mild Cognitive ...

The Sleep-SMART intervention was viewed as acceptable and produced significant improvements in insomnia symptoms. These findings suggest that ...

SleepSMART for Veterans With MCI and Insomnia

CogSMART has been shown to improve cognition, functional capacity, neurobehavioral symptoms, and quality of life in diverse Veteran populations with cognitive ...

0387 Sleep-SMART for Veterans with Mild Cognitive ...

Conclusion The Sleep-SMART intervention was viewed as acceptable and produced significant improvements in insomnia symptoms. These findings suggest that Sleep- ...

A Review of Insomnia Treatments for Patients with Mild ... - PMC

Mild cognitive impairment (MCI) impacts approximately 20% of older adults, with many also experiencing sleep disorders, such as insomnia.

Associations of chronic insomnia, longitudinal cognitive ... - PMC

We found an association between insomnia, cognitive decline, and increased risk for CI. Insomnia with reduced sleep was associated with worse ...

SleepSmart: an IoT-enabled continual learning algorithm ...

Poor sleep quality and quantity can lead to a wide range of negative health outcomes, including obesity, diabetes, and cardiovascular disease.