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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 months of the study up to 12 months

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,130 Total Patients Enrolled

Media Library

Ondansetron (5-HT3 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05657925 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the eligibility criteria for this clinical trial include participants under 30 years of age?

"Participants in this research must be aged between 18 years old and a century."

Answered by AI

What potential risks come with the usage of Ondansetron?

"Our team has assigned Ondansetron a score of 3, as this Phase 3 trial evidences its efficacy and verifies the drug's safety with multiple datasets."

Answered by AI

Are there opportunities for further participants in this medical experiment?

"Based on the information posted to clinicaltrials.gov, this trial has ceased recruiting candidates. Despite being initially posted on February 1st 2023 and last edited December 12th 2022, no further participants are wanted at present; however, there are 26 other trials actively seeking enrolment as of now."

Answered by AI

What type of individuals is this research study looking to include?

"A total of 24 individuals that have experienced sleep syncope in the year before recruitment and meet the additional diagnostic criteria set by American College of Cardiology Guidelines 2017, Calgary Syncope Symptom Score for Structurally Normal Hearts -2 points or higher, and are 18 years old or above with informed consent can be admitted to this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of Ondansetron in the Prevention of Sleep Syncope: The Nineth Prevention of Syncope Trial (POST9)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05657925.