Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies

Study Overview
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Brief Summary
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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.

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

Conditions
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Exercise-Induced Laryngeal Obstruction

Intervention / Treatment
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* Device: Continuous laryngoscopy during exercise test using the HALOS headgear


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male, female or non-binary, aged 18 years or above. Able (in the Investigators opinion) and willing to comply with all study requirements. Able to undergo a CLE test as judged by the clinician, and where a clinical need of the test for the delivery of healthcare has been identified. Exclusion Criteria: Pain, sore areas, broken skin at the site of contact with the headgear. Devices, e.g. cochlear implants, that impede the use of the headgear. Head circumference is less than 50cm or greater than 63cm, reflecting the 3rd centile for females and 97th centile for males, respectively (Bushby, 1992). Exclusion criteria for endoscopy procedures: Skull base/facial surgery or fracture within the previous six weeks Major or life threatening epistaxis within the previous six weeks Trauma to nasal cavity secondary to surgery or injury within the previous six weeks Sino-nasal and anterior skull base tumours/surgery Nasopharyngeal stenosis Craniofacial anomalies Hereditary haemorrhagic telangiectasia Severe movement disorders and/or severe agitation Vasovagal history Bleeding risks Any other exclusion criteria as identified by the current endoscopy procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The study is an interventional clinical trial involving a single group of 30 participants undergoing a continuous laryngoscopy during exercise test with the HALOS headgear.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>Participants will be required to attend a single consultation and screening appointment to discuss the investigation procedure, and this will occur at least a week before the Continuous Laryngoscopy during Exercise (CLE) test. Participants will then attend one appointment for the CLE test. There will be no follow up assessments using the headgear. | Device: Continuous laryngoscopy during exercise test using the HALOS headgear<br>* 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: The headgear is prepared for use. The headgear is fitted onto the participant's head. The endoscope is inserted into the participant. The endoscope is fitted onto the headgear. The CLE test is carried out. The endoscope is removed from the headgear. The endoscope is removed from the participant. The headgear is removed from the participant. The headgear is cleaned and stored.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device effectiveness | The proportion of continuous laryngoscopy during exercise tests where the endoscopy image was clear and stable enough to allow a diagnosis of exercise-induced laryngeal obstruction to be confirmed or ruled out. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device usability rating | The fraction of subjective usability ratings ≥ 4 on the post-test questionnaire. Clinician-reported usability will be scored on a five-point LIKERT scale ranging from 1 (very hard to use) to 5 (very easy to use). Observations will be made throughout the session. | 60 minutes | 
| Device usability subjective feedback | Focussing on any clinician-reported concerns regarding set-up, operation and cleaning. | 60 minutes | 
| Device tolerability ratings | The fraction of subjective tolerability ratings ≥ 3 on the post-test questionnaire. Participant-reported tolerability will be scored on a four-point LIKERT scale ranging from 1 (very intolerable) to 4 (very tolerable) | 60 minutes | 
| Device tolerability subjective feedback | Focussing on any participant-reported concerns regarding the comfort of the headgear including how hot their head felt, weight of the headgear, how secure the headgear felt and the impact of the headgear on their performance during the investigation. | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngoscopy, Exercise-Induced, Laryngeal Obstruction, Headgear