Status:
UNKNOWN
Anxiety Management in Breathlessness.
Lead Sponsor:
University of Leicester
Collaborating Sponsors:
LOROS Hospice Leicester
Conditions:
COPD
Interstitial Lung Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this mixed methods study is to learn about cranial electrotherapy stimulation (CES) using Alpha-Stim AID in anxiety related to breathlessness in advanced lung diseases. The main question\[...
Detailed Description
This is a two-site, mixed-methods, non-commercial interventional scoping study with a parallel non-randomised control group at LOROS Hospice (Leicester) and Northamptonshire Healthcare NHS Foundation ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06066658
Start Date
October 1 2023
End Date
June 1 2024
Last Update
October 4 2023
Active Locations (2)
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1
LOROS Hospice
Leicester, Leicestershire, United Kingdom, LE3 9QE
2
Northamptonshire Healthcare NHS Trust
Northampton, United Kingdom