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

Launched by UNIVERSITY OF CALGARY · Dec 12, 2022

Keywords

ClinConnect Summary

This clinical trial, called the POST9 study, is investigating whether a medication called ondansetron can help prevent a condition known as Sleep Syncope. Sleep Syncope occurs when people wake up from sleep feeling very unwell, often with severe nausea and cramps, and some may faint while trying to get to the bathroom. This study aims to see if taking ondansetron when experiencing nausea can help patients avoid fainting and stay safe.

To participate in the trial, individuals must be at least 18 years old and have experienced at least one episode of Sleep Syncope in the past year. Participants will receive either ondansetron or a placebo (a pill that looks the same but has no active medication) for a period of time and will be monitored for any changes in their symptoms. The researchers hope that this study will not only prove that ondansetron is an effective treatment for Sleep Syncope but also provide important insights into how this condition affects the body. If successful, this could be a breakthrough in managing this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Syncope according to the American College of Cardiology Guidelines 2017
• • 2. ≥1 Sleep Syncope in the year preceding enrolment
• • 3. ≥-2 points on the Calgary Syncope Symptom Score for Structurally Normal Hearts
• • 4. Age ≥ 18 years with informed consent.
• Exclusion Criteria:
• • 1. An inability to give informed consent
• • 2. pregnancy,
• • 3. unwilling or unable to use adequate birth control while on study drug
• • 4. QT interval exceeding 500 ms in the absence of correctable factors.