Table 2.
Summary outcomes for patients receiving modafinil or placebo in the OSA studies
Study/Reference | Measure | Treatment | Mean at baseline | Mean at final visit | Mean (SD) change from baseline to final visit | P-valuea |
---|---|---|---|---|---|---|
4-week study/Pack et al 2001 | MSLT sleep latency (min) | Modafinil 400 mg | 7.4 | 8.6 | <0.05 | |
Placebo | 7.5 | 7.2 | ||||
ESS score | Modafinil 400 mg | 14.2 | 9.6 | <0.001 | ||
Placebo | 14.4 | 12.4 | ||||
4-week study/Dinges and Weaver 2003 | PVT number of lapses (msec) | Modafinil 400 mg | −0.814 (0.426) | 0.112 | ||
Placebo | 0.346 (.550) | |||||
PVT number of lapses transformed (msec) | Modafinil 400 mg | −0.532 (0.177b) | 0.01 | |||
Placebo | 0.118 (0.171b) | |||||
PVT median reaction time (msec) | Modafinil 400 mg | −10.343 (4.424b) | 0.01 | |||
Placebo | 4.936 (4.777b) | |||||
12-week study/Black and Hirshkowitz 2005 | MWT sleep latency (min) | Modafinil 200 mg | 1.6 | <0.0001c | ||
Modafinil 400 mg | 1.5 | |||||
Placebo | −1.1 | |||||
ESS score | Modafinil 200 mg | −4.5 | <0.0001c | |||
Modafinil 400 mg | −4.5 | |||||
Placebo | −1.8 | |||||
FOSQ total score | Modafinil 200 mg | 1.92 (2.47) | 0.001d | |||
Modafinil 400 mg | 2.13 (2.61) | |||||
Placebo | 0.84 (1.89) | |||||
FOSQ vigilance | Modafinil 200 mg | 0.48 (0.67) | 0.0007d | |||
Modafinil 400 mg | 0.55 (0.59) | |||||
Placebo | 0.25 (0.54) | |||||
FOSQ general productivity | Modafinil 200 mg | 0.30 (0.45) | 0.0006d | |||
Modafinil 400 mg | 0.33 (0.49) | |||||
Placebo | 0.08 (0.40) | |||||
FOSQ activity | Modafinil 200 mg | 0.41 (0.59) | 0.02d | |||
Modafinil 400 mg | 0.45 (0.65) | |||||
Placebo | 0.20 (0.49) |
For the change from baseline for modafinil versus placebo.
SEM.
For overall and pairwise comparisons of modafinil with placebo.
For overall comparisons of modafinil with placebo.
Abbreviations: SD, standard deviation; OSA, obstructive sleep apnea; MSLT, Multiple Sleep Latency Test; ESS, Epworth Sleepiness Scale; PVT, Psychomotor Vigilance Task; MWT, Maintenance of Wakefulness Test; FOSQ, Functional Outcomes of Sleep Questionnaire.