Conditions: Obstructive Sleep Apnea Hypopnea
Keywords: Excessive Sleepiness Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP Cephalon Cephalon, Inc NUVIGIL
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 395
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 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 post-baseline visit.

Detailed description:

Arms:
arm 1: Armodafinil 250 mg/day arm 2: Armodafinil 150 mg/day arm 3: Placebo

Interventions: intervention 1: Armodafinil 250 mg/day intervention 2: Armodafinil 150 mg/day intervention 3: Placebo
Intervention descriptions: intervention 1: Armodafinil 250 mg once daily in the morning intervention 2: Armodafinil 150 mg once daily in the morning intervention 3: Matching placebo tablets once daily in the morning

Protocol document: