Feasibility of Noninvasive Trigeminal Nerve Stimulation During Exercise
ConditionCOPD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJohns Hopkins University
About this trial
The purpose of this study is to examine 1) effects of cutaneous electrical trigeminal nerve stimulation (eTNS) on respiratory control in healthy volunteers and 2) explore the potential of this approach to mitigate dyspnea in patients with chronic obstructive lung disease (COPD).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18-50 years
BMI 18-30 kg/m²
Ability to provide informed consent and complete study procedures in English
Disqualifiers
Current daytime respiratory impairment such as uncontrolled asthma, uncontrolled COPD, pneumonia, or interstitial lung disease
Use of supplemental oxygen
Pregnancy or breastfeeding
Current use of acetazolamide, Sodium-glucose cotransporter-2 (SGLT2) inhibitors, or daily opioids
Trial design
Design model
Sequential
Treatments tested in this trial
Active Stimulation
Procedure/SurgeryActive Non-Invasive Trigeminal Nerve Stimulation
Sham Stimulation
Procedure/SurgerySham Stimulation
Fan therapy
Procedure/SurgeryHandheld fan
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Healthy VolunteersExperimental treatment 2 interventions
Group B: Participants With COPDExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Proportion of participants with a >4 bpm decrease in heart rate
Trigeminal autonomic engagement. Proportion of participants with a \>4 bpm decrease in heart rate during active eTNS compared to sham stimulation.
Time frame
1 day2
Proportion of enrolled participants who complete all randomized stimulation conditions
Protocol completion rate measured by proportion of enrolled participants who complete all randomized stimulation conditions.
Time frame
1 daySecondary outcomes
1
Minute Ventilation
Minute Ventilation
Time frame
1 day2
Dyspnea severity as assessed by the Borg CR10 scale
Borg CR10 score before and during stimulation. Scale range 0-10 higher score worse severity
Time frame
1 dayOther outcomes
1
Change in heart rate
changes in heart rate in response to stimulation
Time frame
1 day2
Change in heart rate variability
changes in heart rate variability in response to stimulation
Time frame
1 dayLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Center for Bioengineering Innovation and Design
Collaborator
VentureWell
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: