๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-21

SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment (NCT07397182)

SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment: A Randomized Clinical Trial

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: VA Office of Research and Development

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

Insomnia is a transdiagnostic health problem affecting the physical, cognitive, emotional, and social functioning of Veterans. Importantly, chronic insomnia may be a modifiable risk factor for progression to serious health conditions, such as mild cognitive impairment (MCI) and dementia. Sleep Symptom Management and Rehabilitation Therapy (SleepSMART) was developed as an adapted form of Cognitive Behavioral Therapy for Insomnia (CBT-I) specifically designed for older Veterans with cognitive impairments. SleepSMART focuses on enhancing CBT-I by providing supportive cognitive strategies to boost treatment learning and adherence. In a recent pilot investigation, SleepSMART was found to be feasible, acceptable, and demonstrated preliminary efficacy among a sample of Veterans with co-morbid insomnia and MCI. This proposed investigation aims to conduct a randomized controlled trial investigating the effectiveness of SleepSMART, compared to standard CBT-I in older Veterans with insomnia and MCI.

Who can join: Review the eligibility criteria below.

Location: VA San Diego Healthcare System, San Diego, CA โ€” San Diego, California

Age range: 60 Years

๐Ÿงช Interventions in This Study

  • Cognitive BehavioralTherapy for Insomnia (CBT-I) (BEHAVIORAL)
  • SleepSMART (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • VA San Diego Healthcare System, San Diego, CA โ€” San Diego, California

๐Ÿ“ž Contact the Study Coordinator

Phone: (858) 855-8585

Email: erin.almklov@va.gov

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Insomnia clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—