COPDNCT07686302
Feasibility of Noninvasive Trigeminal Nerve Stimulation During Exercise
A study testing Active Stimulation and Fan therapy in people with COPD, run by Johns Hopkins University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Active Stimulation and Fan therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-50 years
- BMI 18-30 kg/m²
- Ability to provide informed consent and complete study procedures in English
- Adults aged 40-75 years
- Confirmed diagnosis of COPD by spirometry (post-bronchodilator Forced Expiratory Volume (FEV1) /Forced Vital Capacity (FVC) <0.70) or provider documentation in medical records
- Modified Medical Research Council (mMRC) dyspnea grade ≥2
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- Stable COPD (no exacerbation requiring hospitalization, systemic corticosteroids, 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
Who cannot join
- 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
- History of claustrophobia or panic disorder
- Metallic implants in the craniofacial or cervical region that may interfere with electrode placement or electrical stimulation
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- 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
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Noninvasive Trigeminal Nerve Stimulation for Dyspnea: Mechanistic Characterization in Healthy Volunteers and Feasibility in COPD
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
- COPD
- Being tested
- Active Stimulation, Sham Stimulation, Fan therapy
- Keywords
- dyspnea, Control of breathing, neural stimulation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active StimulationProcedure or surgery
Active Non-Invasive Trigeminal Nerve Stimulation
Sham StimulationProcedure or surgery
Sham Stimulation
Fan therapyProcedure or surgery
Handheld fan
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Not described Receives: Procedure: Active Stimulation; Procedure: Sham Stimulation |
| Participants With COPD | Experimental | Not described Receives: Procedure: Active Stimulation; Procedure: Sham Stimulation; Procedure: Fan therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Secondary outcomes (2)
Minute Ventilation
Minute Ventilation
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Bioengineering Innovation and Design, VentureWell
- Responsible party
- Sponsor
- Investigators
- Luu Pham, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686302
- Sponsor's protocol ID
- IRB00551380
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Trigeminal Nerve Stimulation for Dyspnea: Mechanistic Characterization in Healthy Volunteers and Feasibility in COPD
- ClinicalTrials.gov ID
- NCT07686302
- Acronym / sponsor ID
- IRB00551380
- Conditions
- COPD
- Keywords
- dyspnea, Control of breathing, neural stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Center for Bioengineering Innovation and Design, VentureWell
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Procedure: Active Stimulation, Procedure: Sham Stimulation |
| Participants With COPD | Experimental | Procedure: Active Stimulation, Procedure: Sham Stimulation, Procedure: Fan therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults aged 18-50 years
- BMI 18-30 kg/m²
- Ability to provide informed consent and complete study procedures in English
- Adults aged 40-75 years
- Confirmed diagnosis of COPD by spirometry (post-bronchodilator Forced Expiratory Volume (FEV1) /Forced Vital Capacity (FVC) <0.70) or provider documentation in medical records
Key exclusion criteria (24 listed)
- 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
- History of claustrophobia or panic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active StimulationActive Non-Invasive Trigeminal Nerve Stimulation | Procedure or surgery | Healthy Volunteers, Participants With COPD |
| Sham StimulationSham Stimulation | Procedure or surgery | Healthy Volunteers, Participants With COPD |
| Fan therapyHandheld fan | Procedure or surgery | Participants With COPD |
Primary outcome
Proportion of participants with a >4 bpm decrease in heart rate
Time frame: 1 day
Trigeminal autonomic engagement. Proportion of participants with a >4 bpm decrease in heart rate during active eTNS compared to sham stimulation.
Proportion of enrolled participants who complete all randomized stimulation conditions
Time frame: 1 day
Protocol completion rate measured by proportion of enrolled participants who complete all randomized stimulation conditions.
2 secondary outcomes
Minute Ventilation
Time frame: 1 day
Dyspnea severity as assessed by the Borg CR10 scale
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luu Pham, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Active Stimulation and Fan therapy in people with COPD, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luu Pham, MD (410-550-2118, luu.pham@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a >4 bpm decrease in heart rate (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.