NCT07686302

Brief 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

COPD

Keywords

dyspneaControl of breathingneural stimulation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 day

Secondary Outcomes (2)

  • Minute Ventilation

    1 day

  • Dyspnea severity as assessed by the Borg CR10 scale

    1 day

Other Outcomes (2)

  • Change in heart rate

    1 day

  • Change in heart rate variability

    1 day

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL
Procedure: Active StimulationProcedure: Sham Stimulation

Participants With COPD

EXPERIMENTAL
Procedure: Active StimulationProcedure: Sham StimulationProcedure: Fan therapy

Interventions

Active StimulationPROCEDURE

Active Non-Invasive Trigeminal Nerve Stimulation

Healthy VolunteersParticipants With COPD
Sham StimulationPROCEDURE

Sham Stimulation

Healthy VolunteersParticipants With COPD
Fan therapyPROCEDURE

Handheld fan

Participants With COPD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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
  • 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
  • Stable COPD (no exacerbation requiring hospitalization, systemic corticosteroids, or antibiotic therapy within the preceding 6 weeks)
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Luu Pham, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luu Pham, MD

CONTACT

410-550-2118luu.pham@jhmi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

July 7, 2026

Record last verified: 2026-06