Study of Ondansetron in the Prevention of Sleep Syncope: The Nineth Prevention of Syncope Trial (POST9)

Trial interventions: Randomization will be to ondansetron 8 mg sublingual tablets or matching placebo tablets kept at the bedside, to be used upon awakening with premonitory nausea. This is a commonly used dose for rapid treatment of nausea. Randomization: Patients will be randomized into two treatment groups will be carried out centrally with a randomization scheme using a computerized algorithm. Medication containers will be filled and labelled with the randomization code number centrally. The investigators will complete a screening log of eligible but nonrandomized patients that will contain demographic data and the reason for non-randomization. Followup: Study nurse coordinators will see the patients in clinic at baseline, 3 months, 6 months, 9 months, and 12 months. The 6-month visit will be the visit during which the patients will be crossed over from one arm to the other. The total study duration will be 52 weeks for each participant. Patients will be asked to notify the study nurse if they experience a premonitory nausea awakening either with or without an ensuing syncope. Pill counts will be conducted to confirm the number of events.