Using non-invasive techniques to relieve breathlessness in COPD patients
Alleviating Dyspnea With Non-Invasive Neuromodulation : A Feasibility Sham-Controlled Randomized Trial
This study is testing if non-invasive treatments like nerve stimulation can help people with severe COPD breathe easier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Trial ID | NCT06985628 on ClinicalTrials.gov |
What this trial studies
This trial aims to assess the feasibility of non-invasive neuromodulation techniques, specifically transcutaneous vagal nerve stimulation (tVNS) and transcutaneous electrical nerve stimulation (TENS), to alleviate dyspnea in patients with severe chronic obstructive pulmonary disease (COPD). Participants will be randomly assigned to receive either the active treatment or a sham treatment, with their dyspnea levels measured through various assessments including cardiopulmonary exercise testing. The study will follow a single-blinded design, ensuring that participants are unaware of which treatment they receive while researchers analyze the data. The goal is to determine if these neuromodulation techniques can effectively reduce the perception of dyspnea in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with severe COPD who experience significant chronic dyspnea and are referred for pulmonary rehabilitation.
Not a fit: Patients with concurrent pulmonary restrictive features or neurological disorders that could be affected by neurostimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new non-invasive treatment option for patients suffering from severe dyspnea due to COPD.
How similar studies have performed: While the approach of using non-invasive neuromodulation for dyspnea is innovative, similar studies have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Severe COPD (between FEV1 20-50%, FEV1/FVC \< 0.7, and smoking history of ≥ 10 pack-years, 3rd-4th grade on the dyspnea scale modified Medical Research Council (mMRC), COPD Assessment Test (CAT) score ≥ 10) * Significant chronic dyspnea for at least 6 months * Referred for pulmonary rehabilitation * Physical capability to undergo submaximal constant work rate (CRW) * Ability to comprehend the implications of the procedures and follow-up visits and provide free informed consent Exclusion Criteria: * Presence of concurrent pulmonary restrictive features * Neurological disorders susceptible to be influenced by neurostimulation procedures, including epilepsy, Parkinson's disease, trigeminal neuralgia, dysautonomia, and vagal disorders * Unstable arrhythmias, and other cardiac instabilities * Patients with cardiac pacemakers, defibrillators, or other metal implants * Patients who have undergone pulmonary resection resulting in the absence of pulmonary lobe(s) or complete lung * Other serious dyspneic conditions, such as anemia, heart failure with decreased ejection fraction, or mitochondrial dysfunction * Pregnancy * Active infections * Known reactions or intolerance to tVNS or trigeminal TENS Patients must have no moderate-to-severe exacerbations (defined as an increase in symptoms for more than 3 days requiring corticosteroids or antibiotics, or hospitalisation) for at least one month before the baseline visit and at least one month before the first experimental visit (W0 visit). Participants that were randomized yet experience an exacerbation between the first (at week 0) and second (at week 2) experimental visits will be removed from the trial. \*Abbreviations : COPD : chronic obstructive pulmonary disease FEV1 : Forced Expiratory Volume in one second FVC : Forced vital capacity tVNS : Transcutaneous vagal nerve stimulation TENS : Transcutaneous electrical nerve stimulation
Where this trial is running
Sherbrooke, Quebec
- Centre hospitalier universitaire de Sherbrooke (CHUS) — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Joël St-Pierre, MD MSc candidate — Université de Sherbrooke
- Study coordinator: Simon Couillard, MD MSc
- Email: s.couillard@usherbrooke.ca
- Phone: 819-346-1110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.