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Tilt Table vs Recorder Study for Fainting (STUTTER Trial)

N/A

Recruiting

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of syncope (defined in 2017 ACC/AHA/HRS guidelines) within the prior 12 months

Age 50 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

STUTTER Trial Summary

This trial will compare how well two standard syncope therapies work in terms of speed of diagnosis.

Who is the study for?

This trial is for people aged 50 or older who have fainted in the last year and still don't know why, even after a physical exam and heart rhythm test. They shouldn't be at high risk of dying from the fainting, able to agree to participate, and can come back for check-ups.Check my eligibility

What is being tested?

The study is comparing two standard ways to figure out why someone faints: using a tilt table that changes their position or putting in a tiny device under the skin that records heart activity over time.See study design

What are the potential side effects?

Tilt table testing might cause brief dizziness, nausea, or more fainting during the test. The implantable recorder could lead to infection at the site of insertion, minor bleeding, or pain.

STUTTER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had fainting episodes in the last year.

Select...

I am 50 years old or older.

STUTTER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to diagnosis

STUTTER Trial Design

1Treatment groups

Experimental Treatment

Group I: All eligible participantsExperimental Treatment2 Interventions

All eligible participants are randomly assigned to one of two interventions- early Head-Up Tilt Table procedure or early Implantable Loop Recorder. The assignment is random and at a 1:1 ratio between the two strategies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Implantable Loop Recorder

2010

N/A

~60

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,114 Total Patients Enrolled

Media Library

Head Up Tilt Table (HUT) Clinical Trial Eligibility Overview. Trial Name: NCT03974412 — N/A

Fainting Research Study Groups: All eligible participants

Fainting Clinical Trial 2023: Head Up Tilt Table (HUT) Highlights & Side Effects. Trial Name: NCT03974412 — N/A

Head Up Tilt Table (HUT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03974412 — N/A

Frequently Asked Questions

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

How many participants have enlisted in this clinical experiment?

"Affirmative. According to information hosted on clinicaltrials.gov, the study which was first posted on May 28th 2019 is recruiting participants as of this moment in time. The two sites involved must find a total of 20 individuals between them."

Answered by AI

Is enrollment currently underway for this experiment?

"Per the details on clinicaltrials.gov, this trial is still recruiting eligible participants. The study was initially posted on May 28th 2019 and its information has been updated as recently as July 12th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Syncope Trial to Understand Tilt Testing Early or Recorders Study

Roopinder Sandhu 2019. "Syncope Trial to Understand Tilt Testing Early or Recorders Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03974412.