Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Columbia University
- Study ID
- NCT07794605
- Status
- Not Yet Recruiting
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Conditions
- Intracerebral Hemorrhage (ICH)
- Traumatic Brain Injury (TBI) Patients
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
Severe brain injuries can leave people in states where they are unconscious or only partly aware, such as a coma. These conditions are common after injuries like head trauma or bleeding in the brain. One of the biggest challenges for doctors is knowing if - or when - a patient will wake up and regain awareness. This research study is being done to determine if patterns in brain activity during sleep (measured by EEG) can help doctors better predict how quickly someone will wake up and recover after a serious brain injury, as well as how well they might do in the long term. It also aims to develop new ways of using EEG to track how the brain's networks heal and reconnect over time.
Key Dates
- First listed
- Aug 31, 2026
- Start date
- Sep 1, 2026
- Status verified
- Aug 2026
- Primary completion
- Sep 1, 2030
- Completion
- Sep 1, 2031
Study Design
- Enrollment
- 230 participants (estimated)
Arms
- Arm: Intracerebral Hemorrhage and Traumatic Brain InjuryAdult patients with acute neurological injury with Disorders of Consciousness (traumatic brain injury, and intracerebral hemorrhage).
Primary Outcome Measure
P-value for prediction of the detection of cognitive motor dissociation (CMD) [ Time Frame: Day 9 ]
Central Contacts
- Jan Claassen, MD212-305-7236
- Angela Velazquez, MD212-305-6071
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami and Jackson Health System (UM/JHS) | Miami | Florida | 33136 | Ayham Alkhachroum, MD (PRINCIPAL_INVESTIGATOR) |
| Columbia University Medical Center | New York | New York | 10032 | Jan Claassen, MD (PRINCIPAL_INVESTIGATOR) |
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