CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Active AffeX-CT device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05179343
NCT05179343N/ACompleted
CompareCT.gov

Sham Controlled RCT Evaluating the Safety, Acceptability and Efficacy of Autonomic Neuromodulation Using Trans-cutaneous Vagal Stimulation in Uncontrolled Hypertensive Patients: a Pilot Study

Queen Mary University of London·interventional·Posted Jan 5, 2022·Updated Nov 19, 2025

In Brief

A clinical study evaluating Active AffeX-CT device and Sham AffeX-CT device for Uncontrolled Hypertension and High Blood Pressure. Completed, enrolled 63 participants across 1 site.

Detailed Summary

This is a pilot, sham-controlled, double blind, single-site device clinical trial designed to evaluate the safety, acceptability and efficacy of non-invasive autonomic neuromodulation in a cohort of 63 adult patients with uncontrolled high blood pressure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUncontrolled Hypertension, High Blood Pressure
CountriesUnited Kingdom
CollaboratorsHealth Innovation Oxford and Thames Valley (Oxford AHSN)

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 5, 2022
Enrollment StartAug 1, 2022
Primary CompletionSep 8, 2025
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 4.5 years ago

Interventions

Active AffeX-CT devicedevice

(Trans-cutaneous Autonomic Neurostimulation) tAN treatment will be administered using AffeX-CT device (a device based on a totally TENS unit). AffeX device comprises of a battery-operated control unit, two electrode pairs arranged on ear clips and connected to the control unit with electrical leads. The AffeX device generates an electrical signal that is used to stimulate the nerves that naturally control the output from the sympathetic nervous system.

Sham AffeX-CT devicedevice

Sham Totally TENS device. The device is identical to the active device used in the study, but its only purpose is to act as a placebo. The ear-clip electrodes have been modified so that the electric current is not transmitted to the participant.