Zonisamide for the Treatment of Obstructive Sleep Apnea in Overweight/Obese Patients
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
This RCT explores the efficacy of Zonisamide (Zonegran®)on overweight/obese in patients with
moderate to severe obstructive sleep apnea. Patients will be randomized to receive
zonisamide, placebo or nasal continuous positive airway pressure (nCPAP) during 4 weeks. A 5
month open extension part will follow when patients in the tablet groups will all receive
zonisamide. Patients in the open CPAP group will continue with CPAP treatment.
Study hypothesis:
Controlled pharmacological weight reduction with Zonisamide will result in elimination of OSA
and OSA sequels more effectively than nCPAP due to incomplete compliance with the mechanical
treatment and a lack of direct beneficial metabolic effects after nCPAP. Further it is
hypothesized that zonisamide has a direct pharmacological effect on respiratory control
during sleep by its carbonic anhydrase inhibitory effects and this will result in a reduction
of sleep disordered breathing.