HALOS Headgear Device Development Study
Research type
Research Study
Full title
Safe and Effective Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies (HALOS) – a Device Development Study
IRAS ID
293234
Contact name
Tristan Payne
Contact email
Sponsor organisation
Liverpool University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Summary
Exercise-induced laryngeal obstruction (EILO) is a condition in which the larynx, or voice box, narrows during high-intensity exercise, and is often mis-diagnosed. A test called a Continuous Laryngoscopy during Exercise (CLE) test can be performed, where a flexible camera is inserted through the nose and positioned at the back of the throat. While the patient exercises, the camera image can be used to identify the presence of EILO.
During the CLE test it is important that the part of the camera that remains outside the body is held securely in position near the forehead so that a clear and stable image is obtained using a headgear to secure the camera to the patient’s head.
There are no headgears available on the market, so we have designed and manufactured one called HALOS (Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies).
This study is to ensure that HALOS is suitable for use, and to check we have understood and minimised the risks associated with the headgear. The headgear can then be used routinely within the Trust, improving the care that offered to patients.We will recruit 30 male or female participants who need to undergo a CLE test. The study will be conducted at Broadgreen Hospital, Liverpool, UK. Before the CLE test, participants will attend a screening appointment to discuss the procedure. There will be no follow-up appointments.
During the CLE test, the participants will wear the HALOS headgear while exercising, and the clinician will monitor the image from the camera for signs of EILO. After the test, participants will be asked how tolerable the headgear was, and if they have any concerns about any aspect of it. The clinician will also record how clear and stable the camera image was, how easy it was to use, and any concerns about any aspect of it.
Summary of results
The way EILO is diagnosed varies between hospitals. At this NHS Trust, EILO is usually diagnosed using expert clinical judgement and observations during exercise. A more reliable way of diagnosing EILO is with Continuous Laryngoscopy during Exercise (CLE) testing, which gives us a view of the larynx during exercise.
During a CLE test, an endoscope or a small flexible camera is positioned at the back of the throat to give a view of the larynx. During exercise, the images from the camera help work out whether, and by how much, the larynx is causing an airway obstruction. It is important that the endoscope is stable during the test, so a headgear is necessary to hold the body of the endoscope near the forehead.
There is no commercial headgear available to perform this task, so we have designed and manufactured the HALOS headgear.
To learn more about the safety and effectiveness of the HALOS headgear, we recruited 30 participants and use the headgear during CLE testing. After the test, we asked the clinician whether the headgear worked and how easy it was to use. We also asked the participants how comfortable it was to wear.
This study raised no concerns about how well the headgear works and will enable the Trust to provide the CLE test on-premises. This in turn will allow the Trust to deliver a better service to patients. We also understand more about how easy the headgear is to use, and how tolerable it is to wear, which will enable the design to be further improved.
Breathing pattern disorders have a variety of causes, including a condition called exercise-induced laryngeal obstruction (EILO). In EILO, the larynx, or voice box, narrows during high-intensity exercise and causes breathing difficulties.
Accurately diagnosing EILO is not always straightforward because the symptoms are like those caused by other types of condition, including asthma.
REC name
West of Scotland REC 4
REC reference
21/WS/0140
Date of REC Opinion
2 Dec 2021
REC opinion
Further Information Favourable Opinion