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Behavioral Intervention

tVNS for Stress

N/A
Waitlist Available
Led By Liva LaMontagne, Dr. Psych.
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergraduate student (ages 18-30)
Must own a smartphone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to the end of the intervention phase (4 weeks)
Awards & highlights

Study Summary

This trial is testing two new methods to improve stress and sleep in college students: electrical stimulations of the vagus nerve, and a mindfulness mobile app.

Eligible Conditions
  • Stress
  • Sleep
  • Transcutaneous Electrical Nerve Stimulation
  • Vagus Nerve Stimulation
  • Mindfulness

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the end of the intervention phase (4 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the end of the intervention phase (4 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of the combined tVNS + mindfulness intervention as assessed by participant self-report of acceptability using the Acceptability of Intervention Measure (AIM)
Perceived stress as assessed by participant self-report on the Perceived Stress Scale (PSS)
Sleep quality as assessed by participant self-report on the Pittsburgh Sleep Quality Index (PSQI)

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: tVNS + mindfulnessExperimental Treatment2 Interventions
Transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Group II: ControlActive Control1 Intervention
Control number puzzle task delivered via mobile device
Group III: Mindfulness onlyActive Control1 Intervention
Group IV: Sham + mindfulnessPlacebo Group2 Interventions
Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tVNS
2019
N/A
~100
Mindfulness
2014
Completed Phase 3
~2910

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,333 Previous Clinical Trials
714,516 Total Patients Enrolled
Liva LaMontagne, Dr. Psych.Principal InvestigatorUniversity of Florida
Sarah Bottari, M.S.Principal InvestigatorUniversity of Florida

Frequently Asked Questions

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

Does the age restriction for this research extend past twenty years of age?

"This clinical trial seeks to recruit patients aged between 18 and 30. Those who are younger than the specified age bracket have 60 other trials available, while those above 65 can consider 179 alternate studies."

Answered by AI

Does this investigation currently require additional participants?

"This medical trial is currently recruiting, as evidenced by its presence on clinicaltrials.gov with an initial posting date of February 9th 2022 and last update being March 10th 2022."

Answered by AI

Is it possible for me to register in this clinical trial?

"To be eligible for this clinical trial, patients should experience psychological distress and must fit within the 18-30 year old age bracket. Approximately 60 individuals are needed to participate in the study."

Answered by AI

How many subjects are being monitored as part of this research?

"Affirmative. According to information available on clinicaltrials.gov, this research is currently recruiting participants who have been posted since February 9th 2022 and updated as recently as March 10th 2022. 60 individuals need to be signed up from a single site for the experiment to commence."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Met criteria
~24 spots leftby Mar 2025