Exercise-Induced Laryngeal Obstruction
Conditions
Keywords
Laryngoscopy, Exercise-Induced, Laryngeal Obstruction, Headgear
Brief 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.
Interventions
DEVICEContinuous 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.
Sponsors
Liverpool University Hospitals NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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). *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Continuous Laryngoscopy During Exercise Tests | 30 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Device Usability Rating of 4 or 5 | 60 minutes | 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). |
| Device Usability Subjective Feedback | 60 minutes | Focussing on any clinician-reported concerns regarding set-up, operation and cleaning. |
| Percentage of Participants Scoring Device Tolerability as 3 or 4 | 60 minutes | 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). |
| Device Tolerability Subjective Feedback | 60 minutes | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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:
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. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Participants | — |
|---|---|---|
| Age, Continuous | 35 years | — |
| Form of exercise Stationary bike | 6 Participants | — |
| Form of exercise Treadmill | 23 Participants | — |
| Head circumference | 56.5 centimetres | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Scope used Ambu aScope 4 RhinoLaryngo endoscope | 26 Participants | — |
| Scope used XION Video Nasopharyngoscope EV-NC endoscope | 3 Participants | — |
| Sex/Gender, Customized | — | — Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
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.
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants | Percentage of Participants With Continuous Laryngoscopy During Exercise Tests | 100 percentage of participants |
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.
Time frame: 60 minutes
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants | Device Tolerability Subjective Feedback | Comments related to how stable the headgear felt | Did not comment on this | 12 Participants |
| Participants | Device Tolerability Subjective Feedback | Comments related to how heavy the headgear felt | Raised as an issue, but they did did not feel impacted by this when exercising. | 6 Participants |
| Participants | Device Tolerability Subjective Feedback | Comments related to how heavy the headgear felt | Raised as an issue, but didn't indicate whether they felt impacted by this when exercising. | 2 Participants |
| Participants | Device Tolerability Subjective Feedback | Comments related to how heavy the headgear felt | Commented that this was acceptable. | 11 Participants |
| Participants | Device Tolerability Subjective Feedback | Comments related to how heavy the headgear felt | Did not comment on this | 10 Participants |
| Participants | Device Tolerability Subjective Feedback | Comments related to how hot their head felt | Raised as an issue, but they did did not feel impacted by this when exercising. | 3 Participants |
| Participants | Device Tolerability Subjective Feedback | Comments related to how hot their head felt | Raised as an issue, but didn't indicate whether they felt impacted by this when exercising. | 2 Participants |
| Participants | Device Tolerability Subjective Feedback | Comments related to how hot their head felt | Commented that this was acceptable. | 4 Participants |
| Participants | Device Tolerability Subjective Feedback | Comments related to how hot their head felt | Did not comment on this | 20 Participants |
| Participants | Device Tolerability Subjective Feedback | Comments related to how stable the headgear felt | Raised as an issue, but they did did not feel impacted by this when exercising. | 2 Participants |
| Participants | Device Tolerability Subjective Feedback | Comments related to how stable the headgear felt | Raised as an issue, but didn't indicate whether they felt impacted by this when exercising. | 2 Participants |
| Participants | Device Tolerability Subjective Feedback | Comments related to how stable the headgear felt | Commented that this was acceptable. | 13 Participants |
Secondary
Device Usability Subjective Feedback
Focussing on any clinician-reported concerns regarding set-up, operation and cleaning.
Time frame: 60 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants | Device Usability Subjective Feedback | Did not comment on usability | 26 Participants |
| Participants | Device Usability Subjective Feedback | Ease of tightening headgear raised as an issue, caused by participant's small head | 1 Participants |
| Participants | Device Usability Subjective Feedback | Ease of tightening headgear raised as an issue, unknown cause | 2 Participants |
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).
Time frame: 60 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants | Percentage of Participants Scoring Device Tolerability as 3 or 4 | 100 percentage of participants |
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).
Time frame: 60 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants | Percentage of Participants With Device Usability Rating of 4 or 5 | 96.6 percentage of participants |