Trial Outcomes & Findings for Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies (NCT NCT05314478)
NCT ID: NCT05314478
Last Updated: 2024-11-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
30 minutes
Results posted on
2024-11-08
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Sex not collected
Baseline characteristics by cohort
| Measure |
Participants
n=29 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.
|
|---|---|
|
Age, Continuous
|
35 years
n=29 Participants
|
|
Head circumference
|
56.5 centimetres
n=29 Participants
|
|
Form of exercise
Treadmill
|
23 Participants
n=29 Participants
|
|
Form of exercise
Stationary bike
|
6 Participants
n=29 Participants
|
|
Scope used
Ambu aScope 4 RhinoLaryngo endoscope
|
26 Participants
n=29 Participants
|
|
Scope used
XION Video Nasopharyngoscope EV-NC endoscope
|
3 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: 30 minutesThe 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.
Outcome measures
| Measure |
Participants
n=29 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.
|
|---|---|
|
Percentage of Participants With Continuous Laryngoscopy During Exercise Tests
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 60 minutesThe 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).
Outcome measures
| Measure |
Participants
n=29 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.
|
|---|---|
|
Percentage of Participants With Device Usability Rating of 4 or 5
|
96.6 percentage of participants
|
SECONDARY outcome
Timeframe: 60 minutesFocussing on any clinician-reported concerns regarding set-up, operation and cleaning.
Outcome measures
| Measure |
Participants
n=29 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.
|
|---|---|
|
Device Usability Subjective Feedback
Ease of tightening headgear raised as an issue, caused by participant's small head
|
1 Participants
|
|
Device Usability Subjective Feedback
Ease of tightening headgear raised as an issue, unknown cause
|
2 Participants
|
|
Device Usability Subjective Feedback
Did not comment on usability
|
26 Participants
|
SECONDARY outcome
Timeframe: 60 minutesThe 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).
Outcome measures
| Measure |
Participants
n=29 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.
|
|---|---|
|
Percentage of Participants Scoring Device Tolerability as 3 or 4
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 60 minutesFocussing 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.
Outcome measures
| Measure |
Participants
n=29 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.
|
|---|---|
|
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
|
|
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
|
|
Device Tolerability Subjective Feedback
Comments related to how heavy the headgear felt · Commented that this was acceptable.
|
11 Participants
|
|
Device Tolerability Subjective Feedback
Comments related to how heavy the headgear felt · Did not comment on this
|
10 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
|
|
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
|
|
Device Tolerability Subjective Feedback
Comments related to how hot their head felt · Commented that this was acceptable.
|
4 Participants
|
|
Device Tolerability Subjective Feedback
Comments related to how hot their head felt · Did not comment on this
|
20 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
|
|
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
|
|
Device Tolerability Subjective Feedback
Comments related to how stable the headgear felt · Commented that this was acceptable.
|
13 Participants
|
|
Device Tolerability Subjective Feedback
Comments related to how stable the headgear felt · Did not comment on this
|
12 Participants
|
Adverse Events
Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Tristan Payne
Liverpool University Hospitals NHS Foundation Trust
Phone: 01517064553
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place