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5-HT3 Receptor Antagonist

Ondansetron for Sleep Fainting (POST9 Trial)

Phase 3
Waitlist Available
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥1 Sleep Syncope in the year preceding enrolment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 months of the study up to 12 months
Awards & highlights

POST9 Trial Summary

This trial will test if anti-nausea medication can prevent syncope in patients with Sleep Syncope who awaken with nausea. It could lead to the first effective treatment & understanding of brain-initiated syncope in the community. #MedicalResearch #Syncope

Who is the study for?
This trial is for adults over 18 who experience fainting during sleep and meet certain criteria for vasovagal syncope. They must have had at least one such episode in the past year and score a specific minimum on a syncope symptom scale. Pregnant individuals, those unable to consent, or not using birth control, as well as anyone with a long QT interval on an ECG are excluded.Check my eligibility
What is being tested?
The study tests if Ondansetron (an anti-nausea medication) can prevent fainting when taken sublingually upon waking with nausea due to Sleep Syncope. It's compared against a placebo in a double-blind crossover design where participants switch between treatments after six months.See study design
What are the potential side effects?
Ondansetron may cause headaches, constipation or diarrhea, dizziness, and fatigue. Rarely it can affect heart rhythm which is why people with long QT intervals cannot participate.

POST9 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have fainted during sleep at least once in the last year.

POST9 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 months of the study up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months of the study up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
nausea event causing the patient to awake and prevented from progressing to syncope
Secondary outcome measures
EQ-5D-3L
Generalized Anxiety Disorder score
Hospital Anxiety and Depression Scale (HADS)
+3 more

POST9 Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: OndansetronActive Control1 Intervention
ondansetron 8 mg prn sublingually when awakening with nausea. as per the FDA label for ondansetron.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo will be identical in appearance to the active treatment pill.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
797 Previous Clinical Trials
875,065 Total Patients Enrolled

Media Library

Ondansetron (5-HT3 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05657925 — Phase 3
~16 spots leftby Dec 2026
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