Non-invasive Vagus Nerve Stimulation (nVNS) and Cognition in Young Adult Vapers - A Pilot Study

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Temple University
Study ID
NCT06804109
Status
Recruiting
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Conditions

  • Vaping

Eligibility Criteria

Sex
ALL
Age
18 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • Active nVNS — DEVICE
    2-min transcutaneous nVNS stimulation using portable Truvaga Plus Device (electroCore Inc., Rockaway, NJ).
  • Control nVNS — DEVICE
    2-min control stimulation using portable Truvaga Plus Device (electroCore Inc., Rockaway, NJ).

Study Details

The purpose of this study is to assess the effects of non-invasive vagus nerve stimulation (nNVS) on cognitive functioning in the users of e-cigarettes or vaping products. The investigators will use a digital wellness companion product (TRUVAGA™ device) that provides mild transcutaneous nVNS. The participants will be randomized to receive either a 2-min nNVS stimulation or control stimulation in the neck region followed by completion of three cognitive tests of attention and executive function.

Key Dates

Start date
Mar 18, 2025
Status verified
Mar 2026
Primary completion
Feb 9, 2027
Completion
Feb 9, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Active Stimulation
    Participants in the active arm will receive a 2-min transcutaneous vagus nerve stimulation using a portable hand-held digital wellness Truvaga Plus device by placing it on the anterolateral cervical area of the neck.
  • Experimental: Control Stimulation
    Participants in the control arm will receive a 2-min transcutaneous stimulation using a portable hand-held digital wellness Truvaga Plus device by placing it on the posterolateral part of the neck (near the overlapping area between the trapezeus muscle and the shoulder).

Primary Outcome Measure

Efficiency of Attentional Networks using the Attention Network task (ANT) [ Time Frame: Immediately after intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Temple UniversityPhiladelphiaPennsylvania19122-

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Temple University· Philadelphia, PA

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