Anxiety Management in Breathlessness.

NCT06066658 | Unknown

• 1 other identifier: 0890
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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\[s\] it aims to answer are:

• Is CES using Alpha-Stim AID acceptable and tolerable as a potential treatment in the management of anxiety in patients who experience breathlessness due to advanced chronic respiratory disease?
• What are the key factors that will inform the design of a study to examine its potential clinical effectiveness? Participants will choose whether they want to trial the CES for eight weeks or be in a parallel control group. They will complete daily diaries, questionnaires about anxiety, breathlessness, sleep, quality of life and depression, and an end of study qualitative interview. Researchers will compare those using the CES and those receiving standard care to see if there are any indications of difference in anxiety and other symptoms experienced.

Conditions

COPD; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Acceptability and tolerability

  qualitative text entries in daily log and analysis of end of study interviews will be triangulated with adverse effects (number of participants experiencing AE thought to be causally related to the CES, severity, and duration) and in comparison to those in control arm. We do not anticipate SAE to be a feature of the study.

  2,4,8 and 12 weeks

Secondary Outcomes (1)

• Anxiety

  baseline, 2, 4, 8 and 12 weeks

Study Arms (2)

Standard care

NO INTERVENTION

Standard care for Help with Breathlessness including medication, cognitive and behavioural strategies

CES

EXPERIMENTAL

8 weeks of 60 minutes a day 100microA a day with four week follow-up with standard care for help with breathlessness

Device: cranial electrotherapy stimulation (Alpha-Stim AID)

Interventions

cranial electrotherapy stimulation (Alpha-Stim AID) DEVICE

Alpha-Stim AID

CES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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.

Sponsors & Collaborators

• University of Leicester: lead
• LOROS Hospice Leicester: collaborator

Study Sites (2)

LOROS Hospice

Leicester, Leicestershire, LE3 9QE, United Kingdom

RECRUITING

Northamptonshire Healthcare NHS Trust

Northampton, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• christina faull, MBBS

  University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Maitland

CONTACT

0116 231 8498; Taramaitland@loros.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non randomised intervention and control both with standard care for breathlessness and anxiety

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: October 4, 2023
• Study Start: October 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)