๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-31

Deep Sleep in Older Adults (NCT07316153)

An Internet of Things Automated Cognitive Behavioral Therapy for Insomnia That Improves Cognition in Older Adults

๐ŸŸก Not Yet Recruiting Phase2 ๐Ÿง  Behavioral & Psychological Program Sponsor: Proactive Life Inc

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

This double blind randomized clinical trial on older independent-living healthy individuals with symptoms of insomnia will harness Cognitive Behavioral Therapy for Insomnia (CBT-I) and augment it with ambulatory data collection devices, personalized digital content, and smart sound and light cues (CBT-I +Internet of Things \[IoT\]+Artificial Intelligence \[AI\]). With this approach, the investigators aim to overcome many of the limitations that CBT-I in the clinic faces: the investigators can implement it in ambulatory settings while providing increased (remote) accessibility to therapy. The investigators will compare the CBT-I +IoT+AI to active controls that also integrate with smart phone devices, including SleepEZ, which is also based on CBT-I, and sleep hygiene education. These active controls will help determine whether CBT-I +IoT+AI is effective at treating insomnia based on the Insomnia Severity Index (ISI) (primary outcome), sleep metrics (secondary outcome), cognitive performance (secondary outcome), and additional outcomes like therapeutic adherence and other mental health assessments. Participants will be asked to track sleep with wearable and nearable devices, complete surveys, and complete cognitive assessments.

Who can join: Review the eligibility criteria below.

Location: SleepSpace โ€” New York, New York

Age range: 65 Years

๐Ÿงช Interventions in This Study

  • CBT-I-IoT-AI (BEHAVIORAL)
  • SleepEZ CBTi (BEHAVIORAL)
  • Sleep Hygiene IoT (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)

  • SleepSpace โ€” New York, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: (732) 668-1250

Email: dan@sleepspace.com

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†—