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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
christina
Faull
christinafaull@loros.co.uk
Tara
Maitland
taramaitland@loros.co.uk
Chronic lower respiratory diseasesOther respiratory diseases principally affecting the interstitiumNeurotic, stress-related and somatoform disorders
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This research uses questionnaire, interview and participant daily diaries to evaluate the potential of an electronic medical device, Cranial Electrotherapy Stimulation (CES), to treat anxiety in people who experience breathlessness due to advanced lung diseases. The study will look to recruit a minimum of 20 participants. Participants will be allocated to either using the CES intervention of a parallel non-randomised control group.
The research will take place over a period of 8 months with individuals participation in the research being 12-14 weeks with 8 weeks treatment duration for the CES intervention. Participants will be identified from attendance at LOROS and Cynthia Spencer Hospices.
Recruitment to the intervention group will be staggered to develop the most effective and safe ways of working, learning from each participant with very close monitoring of adverse effects and acceptability of treatment. A control group will be recruited in parallel with the interventional group recruitment. Participants can choose which group they wish to be in and reasons for their choice will be explored and recorded to inform tertiary objectives regarding feasibility of a future randomised controlled trial.
The current treatment options for patients with anxiety related to breathlessness are medications which commonly have considerable side effects or cognitive and behavioural management strategies which have limitations, especially for frail patients, and are resource intensive. There is therefore an urgent need to develop new approaches.
Robust research for the use of CES is lacking beyond the context of generalised anxiety disorder in mental health services and there has been no research in the context of anxiety related to breathlessness. If shown to be effective, CES could provide a self-managed, relatively inexpensive treatment for this patient group.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Device;
You can take part if:
You may not be able to take part if:
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. Lacks capacity to give informed consent.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Leicester and funded by NIHR Central Commissioning Facility (CCF) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 55682
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