Conditions: Obstructive Sleep Apnea Sleep Hypopnea
Keywords: Excessive Sleepiness Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP Cephalon Cephalon, Inc Nuvigil
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 263
Healthy volunteers: no

Brief summary:
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).

Detailed description:

Arms:
arm 1: Armodafinil 150 mg/day arm 2: Placebo

Interventions: intervention 1: Armodafinil 150 mg/day intervention 2: Placebo
Intervention descriptions: intervention 1: Armodafinil 150 mg once daily in the morning intervention 2: Matching placebo tablets once daily

Protocol document: