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Behavioural Intervention
LLTS for Atrial Fibrillation (LLT-SPANS Trial)
N/A
Recruiting
Led By Stavros Stavrakis, MD, PhD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes
Awards & highlights
LLT-SPANS Trial Summary
This trial is examining the effect of two different frequencies and two different amplitudes of LLTS on heart rate variability in healthy volunteers and patients with atrial fibrillation or heart failure with preserved ejection fraction.
Who is the study for?
This trial is for adults over 21, including healthy individuals and those with Paroxysmal Atrial Fibrillation or Heart Failure with Preserved Ejection Fraction. It's not for those who've had recent strokes or heart attacks, severe heart failure, are pregnant/breastfeeding, have diseases affecting the nervous system, take certain medications, have low ejection fraction in their hearts, frequent fainting spells due to vaso-vagal syncope, a history of vagus nerve surgery (vagotomy), or uncontrolled diabetes/hypertension.Check my eligibility
What is being tested?
The study tests how different settings of Low-Level Tragus Stimulation (LLTS) affect the autonomic nervous system. Specifically looking at two frequencies (5Hz and 20Hz) and two amplitudes related to pain threshold on heart rate variability and brain stem responses in both healthy volunteers and patients with specific heart conditions.See study design
What are the potential side effects?
While side effects aren't detailed here, LLTS may cause discomfort at the stimulation site. Since it involves electrical impulses near the ear where a branch of the vagus nerve is located, some participants might experience sensations like tingling during treatment.
LLT-SPANS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate variability
Stress Test
LLT-SPANS Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Frequency 20Hz; amplitude 1mA below discomfort thresholdExperimental Treatment1 Intervention
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 20Hz; amplitude 1mA below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.
Group II: Frequency 20Hz; amplitude 50% below discomfort thresholdActive Control1 Intervention
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 20Hz; amplitude 50% below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.
Group III: Frequency 5Hz; amplitude 1mA below discomfort thresholdActive Control1 Intervention
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 5Hz; amplitude 1mA below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.
Group IV: Frequency 5Hz; amplitude 50% below discomfort thresholdActive Control1 Intervention
Patients will receive tragus stimulation for 15 minutes using the following settings: Frequency 5Hz; amplitude 50% below discomfort threshold. Continuous ECG will be recorded to assess heart rate variability.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Parasym
2018
N/A
~90
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,833 Total Patients Enrolled
5 Trials studying Heart Failure
367 Patients Enrolled for Heart Failure
Stavros Stavrakis, MD, PhDPrincipal InvestigatorUniversity of Oklahoma
4 Previous Clinical Trials
739 Total Patients Enrolled
1 Trials studying Heart Failure
52 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to cut the nerves to my stomach.I am healthy with no heart or autonomic nervous system diseases.I have had multiple fainting spells due to sudden drops in heart rate and blood pressure.I am not on medications that affect my nervous system's automatic functions.I had a stroke less than 6 months ago.I have severe heart failure.I have had a heart attack in the last 6 months.I have heart failure but my heart still pumps well.I have a serious condition that affects my nervous system's automatic functions.I am older than 21 years.I have episodes of irregular heartbeat.Your heart's pumping ability is less than 50%.My diabetes or blood pressure is not well-managed.
Research Study Groups:
This trial has the following groups:- Group 1: Frequency 20Hz; amplitude 1mA below discomfort threshold
- Group 2: Frequency 20Hz; amplitude 50% below discomfort threshold
- Group 3: Frequency 5Hz; amplitude 1mA below discomfort threshold
- Group 4: Frequency 5Hz; amplitude 50% below discomfort threshold
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor open to participants over 70 years old?
"The requisite qualifications for this clinical trial stipulate that candidates must be between 21 - 90 years old. There are 11 studies dedicated to those under 18, and 496 devoted to individuals over the age of 65."
Answered by AI
Am I able to join the research being conducted for this trial?
"This research is seeking 90 individuals with atrial fibrillation between 21 and 90 years old. Notably, applicants must not suffer from AF, heart failure, coronary artery disease or conditions that affect the autonomic nervous system; both genders are eligible so long as they meet the minimum age requirement."
Answered by AI
How many participants are eligible for this research project?
"Correct. Clinicaltrials.gov data verifies that this clinical trial, which was published on November 30th 2021, is currently recruiting patients. Approximately 90 participants must be recruited from a single medical facility."
Answered by AI
Are there any opportunities to participate in this research endeavor at present?
"Clinicaltrials.gov documents that this clinical trial is actively seeking participants, with initial postings as of November 30th 2021 and the most recent update on December 16th 2021."
Answered by AI
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