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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous laryngoscopy during exercise test using the HALOS headgear | Device | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Continuous Laryngoscopy During Exercise Tests | 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. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Device Usability Rating of 4 or 5 | 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). | 60 minutes |
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Inclusion Criteria:
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:
Any other exclusion criteria as identified by the current endoscopy procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Tristan Payne | Liverpool University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool University Hospitals Nhs Foundation Trust | Liverpool | Merseyside | L7 8XP | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants | 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. 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:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | 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. 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:
|
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Continuous Laryngoscopy During Exercise Tests | 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. | Posted | Number | percentage of participants | 30 minutes |
|
30 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants | 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. 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:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tristan Payne | Liverpool University Hospitals NHS Foundation Trust | 01517064553 | tristan.payne@liverpoolft.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2021 | Dec 1, 2023 | Prot_SAP_000.pdf |
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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.
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|
| Device Usability Subjective Feedback |
Focussing on any clinician-reported concerns regarding set-up, operation and cleaning. |
| 60 minutes |
| Percentage of Participants Scoring Device Tolerability as 3 or 4 | 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). | 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 |
| years |
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| Sex/Gender, Customized | Sex not collected | Sex not collected | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Head circumference | Median | Full Range | centimetres |
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| Form of exercise | Count of Participants | Participants |
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| Scope used | Count of Participants | Participants |
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| Secondary | Percentage of Participants With Device Usability Rating of 4 or 5 | 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). | Posted | Number | percentage of participants | 60 minutes |
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| Secondary | Device Usability Subjective Feedback | Focussing on any clinician-reported concerns regarding set-up, operation and cleaning. | Posted | Count of Participants | Participants | 60 minutes |
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| Secondary | Percentage of Participants Scoring Device Tolerability as 3 or 4 | 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). | Posted | Number | percentage of participants | 60 minutes |
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| Secondary | 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. | Posted | Count of Participants | Participants | 60 minutes |
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| 29 |
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| 29 |
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| Did not comment on this |
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| Comments related to how hot their head felt |
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| Comments related to how stable the headgear felt |
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