Skip to main content
OpenTrials
Completed

NCT Number: NCT03854539

Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

The proposed project tests the hypothesis that salivary alpha amylase concentration is a reliable biomarker of the effect of transdermal vagus nerve stimulation (tVNS) in humans.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

No Condition Salivary Alpha Amylase

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Tech University

Russellville, Arkansas, 72801, United States

About this study

The study examines the capacity of tVNS to alter the concentrations of salivary alpha amylase. Changes in salivary alpha amylase concentrations reflect alteration of CNS structures anatomically linked to the vagus, thus alertation of alpha amylase would indicate the efficacy of tVNS. This study is intended to study basic mechanisms and is not directed toward the treatment of any disease state. Particapants taking part in the study will spend about one hour in a single session.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals

Exclusion criteria

  • NA

Treatment and study plan

Transdermal Vagus Nerve Stimulation

Other

intermittent transdermal stimulation of the aurical vagus

Primary outcomes

  1. Change in Salivary Alpha Amylase concentration.

    Time frame: Within single one hour session change in concentration immediately prior to and following stimulation and 5 minutes post-stimulation

    Biomarker of autonomic arousal level

Secondary outcomes

  1. Change in Heart Rate Variability.

    Time frame: Within single one hour session change in heart rate variability immediately prior to and following stimulation period.

    Change in beat to beat interval.

Sponsors and collaborators

Lead sponsor

Arkansas Tech University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2019
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.