🏛️ Verified NIH Record • Updated 2026-04-22

Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2 (NCT07036705)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: University of California, San Francisco

🩺 Plain-English Summary (8th-Grade Level)

This two-arm randomized trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) to all participants and passive body heating (PBH) sessions using a sauna blanket to half of participants over a 9-week treatment period. Participants are adults aged 18 years or older with insomnia disorder.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (15 items).

Location: Osher Center for Integrative Health — San Francisco, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Night shift or swing shift worker
  • Current or planned routine body heating practices (e.g., saunas, hot tubs, long baths) within 4 hours before bed that are 10 minutes or more in duration (≥2x per week)
  • Pregnant or plans to become pregnant during the participation period
  • Traveling internationally between screening assessment and anticipated post-intervention assessment, or during anticipated post-follow-up assessment period (\~1 week)
  • Other diagnosed sleep disorders or suspected sleep disorders
  • Medical conditions that might increase the risk of passive body heating using an infrared sauna blanket
  • Medication use that might increase the risk of passive body heating using an infrared sauna blanket
  • Mental health disorder that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction
  • Medical condition that may better explain insomnia, require priority treatment, or be exacerbated by time in bed restriction
  • Lifetime diagnosis of a bipolar disorder, psychosis, or other psychotic disorder
  • Current (past 3 months) major depressive disorder

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Osher Center for Integrative Health — San Francisco, California

💰 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 § 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.
🏛️ View Official NIH Record ↗