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Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies
NA trial testing Continuous laryngoscopy during exercise test using the HALOS headgear in Exercise-Induced Laryngeal Obstruction in 30 participants. Completed in 25 August 2023.
| Lead sponsor | Liverpool University Hospitals NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 30 |
| Start date | 24 March 2022 |
| Primary completion | 25 August 2023 |
| Estimated completion | 25 August 2023 |
| Sites | 1 location across United Kingdom |
Liverpool University Hospitals NHS Foundation Trust
18 and older, any sex, with Exercise-Induced Laryngeal Obstruction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The percentage of participants with 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.
| Group | Value | 95% CI |
|---|---|---|
| Participants | 100 |
The percentage of participants where the clinician provided a device usability rating of 4 or 5 on the post-test questionnaire. Device usability is scored on a five-point LIKERT scale ranging from 1 (very hard to use) to 5 (very easy to use).
| Group | Value | 95% CI |
|---|---|---|
| Participants | 96.6 |
Focussing on any clinician-reported concerns regarding set-up, operation and cleaning.
| Group | Value | 95% CI |
|---|---|---|
| Participants | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Participants | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Participants | 26 |
The percentage of participants where the participant provided a device tolerability rating of 3 or 4 on the post-test questionnaire. Device tolerability is scored on a four-point scale of 1 (highly intolerable), 2 (intolerable), 3 (tolerable) or 4 (highly tolerable).
| Group | Value | 95% CI |
|---|---|---|
| Participants | 100 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants | 6 | |
| Participants | 2 | |
| Participants | 11 | |
| Participants | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Participants | 3 | |
| Participants | 2 | |
| Participants | 4 | |
| Participants | 20 |
| Group | Value | 95% CI |
|---|---|---|
| Participants | 2 | |
| Participants | 2 | |
| Participants | 13 | |
| Participants | 12 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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