Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Sleep-disordered breathing Obstructive sleep apnea syndrome
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 60
Healthy volunteers: no

Brief summary:
To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).

Detailed description:
This study will be conducted as a randomized, crossover study of the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea syndrome (OSAS).

Arms:
arm 1: Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later arm 2: Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. arm 3: Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment). arm 4: Placebo was given at bedtime and again 2.5 to 4 hours later.

Interventions: intervention 1: Xyrem (X) intervention 2: Zolpidem (Z) intervention 3: Modafinil (M) intervention 4: Placebo (P)
Intervention descriptions: intervention 1: Xyrem (Sodium Oxybate) Oral Solution intervention 2: Zolpidem 10 mg oral tablets intervention 3: Modafinil Oral Tablets intervention 4: Placebo Oral Solution

Protocol document: