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Table 7.12 Modafinil for the Management of Sleep Disorders Post ABI

Author Year Country Study Design Sample Size Methods Outcome
Kaiser et al. (2010) Switzerland RCT PEDro=9 N=20 Population: TBI=20; Gender: Male=17, Female=3. Treatment Group (n=10): Mean Age=37yr; Severity: Mean GCS=7. Control Group (n=10): Mean Age=43yr; Severity: Mean GCS=8. Intervention: Patients received either 100-200mg modafinil or placebo every morning for 6wk. Outcome Measure: Excessive Daytime Sleepiness (EDS), Fatigue Severity Scale (FSS), Maintenance of Wakefulness Test (MWT). 1.        The modafinil group had greater decreases in EDS scores versus placebo (p<0.005). 2.        On the MWT, a significantly greater improvement was shown for the modafinil group when compared to placebo (8.4± 9.6 versus 0.4± 6.2 min, p=0.04).
Jha et al. (2008) USA RCT PEDro=8 NInitial=51, NFinal=46 Population: TBI=51; Mean Age=38.25yr; Gender: Male=35, Female=16; Mean Time Post Injury=5.77yr. Intervention: The treatment group (n=27) received modafinil (100 mg/d for 3d, then 200 mg/d for 11d, then a maintenance dose of 400 mg/d for 8wk). The control group (n=24) received a placebo. At the end of phase 1 (8wk) both groups crossed-over.Outcome Measure: Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFI), Epworth Sleepiness Scale (ESS). 1.        The change in ESS scores was significantly greater in the modafinil group versus placebo at 4wk (p=0.02) but not at 10wk (p=0.56). 2.        Adverse events for the treatment group included: headaches (29.5%), insomnia (19.6%), fatigue (9.8%), dizziness (7.8%), and tremors (5.9%). Adverse events for placebo: headaches (19.6%) and nasoppharyngitis (5.9%).