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Background: Modafinil is used for improving wakefulness associated with narcolepsy, obstructive sleep apnea, and shift work sleep disorder. The goal of this study is to evaluate alertness and participation in physical therapy and occupational therapy in patients with a first-time diagnosis of traumatic brain injury using modafinil.

Methods: This was a single-center, retrospective, chart review, cohort study of Ochsner Medical Center patients from January 2016 to December 2018. Patients included in the study were 18 years of age or older who were hospitalized due to a traumatic brain injury and received modafinil either by mouth, nasogastric, or enteral feeding tube to help improve alertness. The primary outcome is the change in Glasgow Coma Scale (GCS) score from baseline to 72 hours after initiating modafinil.

Results: One-hundred and Forty patients were included with a mean age of 67.8 years and 59.3% were male. The majority of the patients (52.9 %) were predominantly patients who suffered ischemic stroke. The mean change in GCS score in 72 hours was +0.35 (95% CI [-0.16, 0.88], p=0.177). One of the secondary endpoints was the mean change in course of therapy GCS score which showed significant improvement in neurological function after initiation of modafinil: +1.22 (95% CI [0.64, 1.80], p=0.0001). The percent physical therapy/occupational therapy (PT/OT) session participation at 72-hour post-modafinil initiation was 96.7% compared to 95.7% during the course of therapy. The correlation between increase in GCS score and percent PT/OT therapy session participation was analyzed at 72 hours and throughout the course of therapy, which revealed no significant association (r=0.14 [p=0.0911] and -0.06 [p=0.4881], respectively).

Conclusion: Our study did not find a significant increase in the mean change of GCS score at 72 hours of modafinil use. Although, there were high percentage of patients participated in PT/OT in 72 hours and course of therapy (96.7% and 95.7%), there was no significant statistical correlation between increase in GCS score and PT/OT participation. Randomized studies are needed to further assess the impact of modafinil for treating traumatic brain injury associated sleep-wake disturbances while considering factors such as medication initiation time, appropriate dosage, GCS score, and long-term outcomes.