Conditions: Sleep Apnea, Obstructive Hypopnea Syndrome Excessive Daytime Sleepiness
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 125
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy.

Detailed description:

Arms:
arm 1: Arm 1: Treatment period 1: MK0249; Treatment period 2: Placebo; Treatment period 3: modafinil arm 2: Arm 2: Treatment period 1: Placebo; Treatment period 2: modafinil; Treatment period 3: MK0249 arm 3: Arm 3: Treatment period 1: modafinil; Treatment period 2: MK0249; Treatment period 3: Placebo arm 4: Arm 4: Treatment period 1: MK0249; Treatment period 2: modafinil; Treatment period 3: Placebo arm 5: Arm 5: Treatment period 1: Placebo; Treatment period 2: MK0249; Treatment period 3: modafinil arm 6: Arm 6: Treatment period 1: modafinil; Treatment period 2: Placebo; Treatment period 3: MK0249

Interventions: intervention 1: Comparator: MK0249 intervention 2: Comparator: placebo intervention 3: Comparator: modafinil
Intervention descriptions: intervention 1: Patients will be assigned to receive MK0249 film coated tablet (FCT). The doses of MK0249 that are included for possible investigation (depending upon an adaptive allocation process) are 3 mg, 5 mg, 8 mg, 10 mg, and 12 mg. Study medication will be taken for 14 days, during each of the 3 treatment periods, by mouth (po) once a day (qd). intervention 2: Placebo; Patients will be assigned to receive placebo, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd. intervention 3: Patients will be assigned to receive modafinil 200mg oral compressed tablet (OCT), across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.

Protocol document: