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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Xyrem (Sodium Oxybate) Oral Solution
Zolpidem 10 mg oral tablets
Modafinil Oral Tablets
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, United States
London Health Sciences Centre, Victoria Campus
London, Ontario, Canada
The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI).
The AHI was defined as the incidence(events per hour) of apnea and hypopnea events associated with sleep, determined from the overnight polysomnogram (PSG). An apnea event is characterized by a cessation in airflow lasting \>= 10 seconds, accompanied by oxygen desaturation of \>3% or arousal. An Hyponea event is characterized by a transient reduction in breathing lasting \>= 10 seconds, with clear decrease (\>50%) from baseline in the amplitude of breathing or a decrease \<50% in the amplitude of breathing accompanied by oxygen desaturation of \>3% or arousal.
Time frame: One night of PSG during one night of treatment each per arm.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo Oral Solution