Managing anxiety related to breathlessness in lung disease
A Scoping Study to Evaluate the Potential of an Electronic Medical Device to Treat Anxiety in People Who Experience Breathlessness.
NA · University of Leicester · NCT06066658
This study is testing if a device that uses electrical stimulation can help people with lung disease manage their anxiety related to feeling short of breath.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leicester (other) |
| Locations | 2 sites (Leicester, Leicestershire and 1 other locations) |
| Trial ID | NCT06066658 on ClinicalTrials.gov |
What this trial studies
This study explores the use of cranial electrotherapy stimulation (CES) with the Alpha-Stim AID device to manage anxiety in patients suffering from breathlessness due to advanced chronic lung diseases like COPD and interstitial lung disease. Participants can choose to use the CES device for eight weeks or be part of a control group receiving standard care. Throughout the study, participants will complete daily diaries and questionnaires assessing their anxiety, breathlessness, sleep quality, and overall well-being. The study aims to evaluate the acceptability and tolerability of CES and gather insights for designing future clinical effectiveness studies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced chronic lung diseases who experience significant anxiety related to their breathlessness.
Not a fit: Patients with certain neurological conditions, those with implanted medical devices, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety and improve the quality of life for patients experiencing breathlessness due to lung diseases.
How similar studies have performed: While the use of CES for anxiety management is not widely tested in this specific population, similar approaches have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or above. There is no upper age limit. * Diagnosis of advanced chronic lung disease, including Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), or Pulmonary Fibrosis of any aetiology. * Currently receiving care at LOROS or Cynthia Spencer Hospice. * A score of 3 or 4 on IPOS Q2 for shortness of breath. * A score of 2 or more on IPOS Q3 anxious or worried. * Capable of giving oral and written informed consent to the study. * Agrees to return the Alpha-Stim AID device at the end of the study and not to purchase the device privately during the study. * Estimated prognosis of \>3 months at the time of recruitment. Exclusion Criteria: * Implantation with a pacemaker, cochlear implant, or an implantable cardioverter device (ICD). * Neurological conditions, e.g. brain neoplasm, cerebrovascular events, epilepsy, neurodegenerative disorders, or prior brain surgery. * Currently pregnant or planning a pregnancy. * Involved with any other clinical trial at the time of consent.
Where this trial is running
Leicester, Leicestershire and 1 other locations
- LOROS Hospice — Leicester, Leicestershire, United Kingdom (RECRUITING)
- Northamptonshire Healthcare NHS Trust — Northampton, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: christina faull, MBBS — University of Leicester
- Study coordinator: Tara Maitland
- Email: Taramaitland@loros.co.uk
- Phone: 0116 231 8498
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.
Conditions: COPD, Interstitial Lung Disease