Sleep patterns to help predict waking from brain injury
Official title: Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Run by Columbia University · NCT07794605 · Data updated 2026-11-12
Doctors are testing whether brain activity during sleep can help predict when a person with a serious brain injury will regain awareness.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 230 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Status | Recruiting |
| Started | October 30, 2026 |
| Main results expected | October 30, 2030 |
| Study ends | October 30, 2031 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT07794605 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with non-penetrating TBI or primary ICH who are behaviorally unresponsive by day 2 after injury.
✕Probably not a fit
Patients who awaken early or whose recovery cannot be predicted by sleep EEG features may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study looks at adults with traumatic brain injury or intracerebral hemorrhage who are currently unresponsive. Researchers will analyze sleep EEG patterns, focusing on features like sleep spindles, to see if these markers predict early recovery of consciousness and long-term outcomes. The study builds on prior findings about CMD and sleep architecture, aiming to develop scalable EEG biomarkers for prognosis. No interventions are being tested in this design; the goal is to improve prediction and tracking of brain network recovery over time.
Why it matters
Potential benefit: If successful, this approach could provide a simple, cost-effective way to forecast recovery and guide care decisions.
How similar studies have gone: Prior work suggests CMD and sleep spindle integrity relate to recovery, but applying sleep EEG as a prognostic biomarker is still being evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Adults with non-penetrating traumatic brain injury (TBI) or with primary intracerebral hemorrhage (ICH) (i.e. from hypertension or anticoagulants) who remain behaviorally unresponsive to verbal commands (i.e., comatose vegetative state, or minimally conscious state minus \[MCS-minus, defined as unresponsive with preserved visual fixation/pursuit or localization to noxious stimuli\]) by day 2 after injury Exclusion Criteria: * Evidence of consciousness within 2 days of injury * Uncontrolled seizures * pre-existing disorders of consciousness * deafness
Where it's running
-
Columbia University Medical Center
New York, New York, United States Recruiting -
University of Miami and Jackson Health System (UM/JHS)
Miami, Florida, United States Not yet recruiting
Study contacts
- Study coordinator: Jan Claassen, MD
- Email: jc1439@cumc.columbia.edu
- Phone: 212-305-7236
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.