Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-29
SponsorYale University
About this trial
The goal of this clinical trial is to learn the feasibility and safety of using home-based taVNS in young adults with IBS to manage their IBS-related pain and symptoms. It will also learn about participants' experience in using the home-based taVNS intervention. The main questions it aims to answer are:
* Is it feasible to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? * Is it safe and reported satisfactory to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? Researchers will compare Active to Sham taVNS (a look-alike intervention that contains minimal stimulation) to see if Active taVNS works on managing IBS-related pain and symptoms.
Participants will:
* Take Active or Sham taVNS intervention for a 6-week treatment (twice daily, 30 minutes per session) * Visit the research lab at the initial setup and the end of the 6-week treatment for checkups and tests * Keep a diary of their symptoms and the number of times they use the taVNS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 - 29 years of age;
Men and women;
Diagnosis of IBS from a healthcare provider with current report of pain (volunteers asked to bring provider-verification of IBS diagnosis based on Rome IV criteria to initial study appointment);
Experiencing moderate pain (≥3 out of 10 on numeric rating scale [NRS]) at least 4 days of the week and lasting previous three months;
Disqualifiers
Other chronic pain condition;
Celiac disease or inflammatory bowel disease;
Diabetes mellitus;
severe psychiatric condition requiring inpatient treatment in previous 6 months;
Trial design
Design model
Parallel
Treatments tested in this trial
Home-based taVNS intervention
DeviceHome-based taVNS intervention will be administered using the non-invasive taVNS device, Parasym system (Parasym Health, Inc, London, UK).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Active taVNS interventionExperimental treatment 1 intervention
Group B: Sham taVNSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of implementing taVNS - Retention rates
Feasibility will be assessed by evaluating the retention rate of participants who complete the taVNS sessions at 6 weeks and the follow-up at week 12. Retention rates will be calculated by comparing the number of participants who complete these timepoints with the baseline data.
Time frame
Baseline, week 6, week 122
Adherence of implementing taVNS - Duration of usage
Adherence will be measured using participant self-report data and the data from the taVNS monitoring system. Actual usage time (minutes) will be extracted from the Parasym system recorder to monitor the adherence to the study protocol.
Time frame
week 63
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) in using the taVNS will be measured using self-reported data, including online self-monitoring diary, weekly meetings with the research team, surveys, and focus group interviews. Adverse events (AEs) will be monitored daily using the online diary with a preset form, including a 10-item survey to assess daily AEs of taVNS on 0-10 Likert scales.
Time frame
Baseline, week 6, week 124
Satisfaction in implementing taVNS
Satisfaction in using the taVNS will be measured using self-reported data including online self-monitoring diary, weekly meetings with the research team, surveys, and focus group interviews.
Time frame
Baseline, week 6, week 12Sponsors and contacts
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Yale University
Lead sponsor
Florida State University
Collaborator
Rutgers University
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov