Not yet recruitingNCT07686302Updated Oct 14, 2026

Feasibility of Noninvasive Trigeminal Nerve Stimulation During Exercise

An interventional study of Active Stimulation and Sham Stimulation in COPD, sponsored by Johns Hopkins University. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Supportive care

Updated Oct 14, 2026Start date movedSponsor changedGo to Updates ↓

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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).

Conditions studied

COPD

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Keywords

dyspnea
Control of breathing
neural stimulation

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 40 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Browse Johns Hopkins University studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

Arm1 - Healthy Volunteers

Inclusion Criteria:

Adults aged 18-50 years
18-30 kg/m²
Ability to provide and complete study procedures in English

Exclusion Criteria:

Current daytime respiratory impairment such as uncontrolled asthma, uncontrolled , 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
History of claustrophobia or panic disorder
Metallic implants in the craniofacial or cervical region that may interfere with electrode placement or electrical stimulation
Implanted cardiac or neuroelectric device (e.g., pacemaker, implantable cardioverter-defibrillator (ICD), deep brain stimulator, vagus nerve stimulator, implanted drug pump)
Open, broken, inflamed, infected, or healing skin lesions at or near facial electrode placement sites
Resting heart rate \<60 Beats Per Minute
History of seizure disorder or epilepsy

Arm 2 -COPD

Inclusion Criteria:

Adults aged 40-75 years
Confirmed diagnosis of COPD by spirometry (post-bronchodilator (FEV1) /Forced Vital Capacity (FVC) \<0.70) or provider documentation in medical records
Modified Medical Research Council (mMRC) dyspnea grade ≥2
Stable COPD (no exacerbation requiring hospitalization, systemic , or antibiotic therapy within the preceding 6 weeks)
On stable COPD therapy for at least 4 weeks prior to enrollment
Ability to provide informed consent and complete questionnaires in English
Resting Peripheral Capillary Oxygen Saturation (SpO₂) ≥88% on room air or prescribed supplemental oxygen

Exclusion Criteria:

Unstable cardiovascular disease (e.g., unstable angina, decompensated heart failure, recent MI within 6 months, uncontrolled arrhythmia) or peripheral vascular disease
Patients with cardiovascular disease, including chest pain, heart failure, and aortic stenosis
Resting heart rate \<60 BPM
Implanted cardiac or neuroelectric device (e.g., pacemaker, ICD, deep brain stimulator, vagus nerve stimulator, implanted drug pump)
Metallic implants in the craniofacial or cervical region that may interfere with electrode placement or stimulation
Open, broken, inflamed, infected, or healing skin lesions at or near facial electrode placement sites
Active trigeminal neuralgia or other cranial neuropathy
History of seizure disorder or epilepsy
Severe or uncontrolled psychiatric disorder (e.g., psychosis, severe untreated anxiety or panic disorder) that would impair the ability to participate
Pregnancy or breastfeeding
COPD exacerbation requiring hospitalization, systemic corticosteroids, or antibiotics within the preceding 3 months
Musculoskeletal pain, injury, or any other condition that precludes the use of a stationary bike for Cardiopulmonary Exercise Test (CPET)
Any condition that, in the opinion of the investigator, would compromise participant safety or data integrity

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: Single (Participant)
Enrollment: 40 participants (estimated)

Study arms

Experimental
Healthy Volunteers
Procedure: Active Stimulation · Procedure: Sham Stimulation
Experimental
Participants With COPD
Procedure: Active Stimulation · Procedure: Sham Stimulation · Procedure: Fan therapy

Interventions

ProcedureActive Stimulation
Active Non-Invasive Trigeminal Nerve Stimulation
ProcedureSham Stimulation
Sham Stimulation
ProcedureFan therapy
Handheld fan

What researchers measure

Primary outcomes

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 day
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 day

Secondary outcomes

Minute Ventilation
Minute Ventilation
Time frame: 1 day
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 day

Other outcomes

Change in heart rate
changes in heart rate in response to stimulation
Time frame: 1 day
Change in heart rate variability
changes in heart rate variability in response to stimulation
Time frame: 1 day

Study locations

No study locations are listed for this record.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Sep 2027, 10 months later.

Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 10 months is below that.

Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 14, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered: Jun 30, 2026
First posted: Jul 7, 2026
StartEst.: Nov 1, 2026was Oct 2026
Primary completionEst.: Sep 30, 2027
CompletionEst.: Sep 30, 2027
Last update: Oct 14, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Start date

Oct 1, 2026→Nov 1, 2026

Oct 14, 2026

Sponsor

Collaborators added: VentureWell

Oct 14, 2026

Show all 1 update

Oct 14, 2026
Start date Oct 1, 2026→Nov 1, 2026
Sponsor Collaborators added: VentureWell
+ 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07686302
Lead sponsor: Johns Hopkins University
Collaborators: Center for Bioengineering Innovation and Design, VentureWell
Responsible party: Sponsor
First posted: Jul 7, 2026
Start date: Nov 1, 2026 (estimated)
Primary completion: Sep 30, 2027 (estimated)
Completion: Sep 30, 2027 (estimated)
Last update: Oct 14, 2026

Study contacts

Luu Pham, MD

Contact

luu.pham@jhmi.edu

410-550-2118

Luu Pham, MD

principal investigator · Johns Hopkins University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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