Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT06626334
Eligibility Criteria:
Inclusion Criteria:
* Age greater than or equal to 18 years
* Admitted to a single large academic level I trauma center (Presbyterian/Montefiore hospital) within the first 48 hours of traumatic injury
* Greater than or equal to 1 acute rib fracture
* Pain related to rib fracture(s), by one or more of the following criteria: 1. Pain \>/= 4/10 at rest, 2. Pain \>/= 4/10 with incentive spirometer (IS) use, and/or 3. Inspiratory volume \< 1000 cc
* Anticipated length of stay greater than or equal to 48 hours
* Alert, with capacity to provide informed consent
Exclusion Criteria:
* Mechanical ventilation\* or non-invasive positive pressure ventilation administered for respiratory insufficiency prior to the time of informed consent
* Delirium (positive CAM screening) at the time of informed consent
* Ocular trauma, which may interfere with the mechanism of action
* Traumatic brain injury (TBI) or history of TBI or stroke, which may interfere with the mechanism of action
* Splenectomy upon admission or history of splenectomy, which may interfere with the mechanism of action
* History of significant ocular dysfunction\*\* (i.e., macular degeneration, glaucoma, cataracts), which may interfere with the mechanism of action
* History of cataract surgery, due to the possibility of blue light filtering intraocular lens placement
* History of bipolar disorder or schizophrenia, which could increase the risk of an adverse reaction to light exposure (i.e., acute mania)
* History of dementia, which would compromise the reliability of pain intensity and delirium measures
* Or other condition in which a patient cannot open eyes to receive light intervention or report a pain score \*\*Myopia, hyperopia, and/or astigmatism corrected for with contact lenses or spectacle corrective eyeglasses will NOT be a criterion for exclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06626334
Study Brief:
Protocol Section:
NCT06626334