Anxiety Management in Breathlessness.

Launched by UNIVERSITY OF LEICESTER · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help manage anxiety related to breathlessness in patients with serious lung diseases like Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Lung Disease (ILD). The researchers want to find out if a device called Alpha-Stim AID, which uses a method called cranial electrotherapy stimulation (CES), is an acceptable and helpful treatment for people experiencing anxiety due to their breathing difficulties. Participants will have the option to use the CES device for eight weeks or join a control group that receives standard care. Throughout the study, they will keep daily diaries and fill out questionnaires about their anxiety, breathlessness, sleep quality, and overall well-being.

To be eligible for the trial, participants should be at least 18 years old and have a diagnosis of advanced lung disease. They must also be currently receiving care at LOROS or Cynthia Spencer Hospice and experience significant shortness of breath and anxiety. Participants can expect to share their experiences through questionnaires and interviews, helping researchers understand how effective the CES device may be in reducing anxiety and improving quality of life. It's important to note that certain health conditions, like having a pacemaker or being pregnant, may exclude someone from participating.

Gender

ALL

Eligibility 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.