NCT05314478

Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies

Safe and Effective Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies (HALOS) - a Device Development Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Liverpool University Hospitals NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Exercise-Induced Laryngeal Obstruction

Interventions

Type	Name	Description
DEVICE	Continuous laryngoscopy during exercise test using the HALOS headgear	The participant will undergo the CLE test following standard clinical practice. The order of events of the aspects of the investigation related to the headgear will be: 1. The headgear is prepared for use. 2. The headgear is fitted onto the participant's head. 3. The endoscope is inserted into the participant. 4. The endoscope is fitted onto the headgear. 5. The CLE test is carried out. 6. The endoscope is removed from the headgear. 7. The endoscope is removed from the participant. 8. The headgear is removed from the participant. 9. The headgear is cleaned and stored.

Timeline

• Start date: 2022-03-24
• Primary completion: 2023-08-25
• Completion: 2023-08-25
• First posted: 2022-04-06
• Last updated: 2024-11-08
• Results posted: 2024-11-08

Locations

1 site across 1 country: United Kingdom