Exercise-Induced Laryngeal ObstructionHALOSNCT05314478
Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies
A study testing Continuous laryngoscopy during exercise test using the HALOS headgear in people with Exercise-Induced Laryngeal Obstruction, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise-Induced Laryngeal Obstruction
- What is being tested?
- Continuous laryngoscopy during exercise test using the HALOS headgear
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Mar 2022to 25 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool University Hospitals Nhs Foundation Trust
Liverpool, Merseyside, L7 8XP
About this study
Official title: Safe and Effective Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies (HALOS) - a Device Development Study
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.
Read more
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.
- Conditions
- Exercise-Induced Laryngeal Obstruction
- Being tested
- Continuous laryngoscopy during exercise test using the HALOS headgear
- Keywords
- Laryngoscopy, Exercise-Induced, Laryngeal Obstruction, Headgear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous laryngoscopy during exercise test using the HALOS headgearDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous laryngoscopy during exercise test using the HALOS headgear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (4)
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).
Measured: 60 minutes
Device Usability Subjective Feedback
Focussing on any clinician-reported concerns regarding set-up, operation and cleaning.
Measured: 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).
Measured: 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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start24 Mar 2022
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Exercise-Induced Laryngeal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tristan Payne, Principal investigator, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314478
- Sponsor's protocol ID
- SP0707
- Acronym
- HALOS
- Status last verified
- Oct 2023
- First submitted
- 30 Mar 2022
- Last updated
- 8 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe and Effective Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies (HALOS) - a Device Development Study
- ClinicalTrials.gov ID
- NCT05314478
- Acronym / sponsor ID
- HALOS / SP0707
- Conditions
- Exercise-Induced Laryngeal Obstruction
- Keywords
- Laryngoscopy, Exercise-Induced, Laryngeal Obstruction, Headgear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Device: Continuous laryngoscopy during exercise test using the HALOS headgearParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
- Any other exclusion criteria as identified by the current endoscopy procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous laryngoscopy during exercise test using the HALOS headgearThe 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 | Participants |
Primary outcome
Percentage of Participants With Continuous Laryngoscopy During Exercise Tests
Time frame: 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.
4 secondary outcomes
Percentage of Participants With Device Usability Rating of 4 or 5
Time frame: 60 minutes
Device Usability Subjective Feedback
Time frame: 60 minutes
Percentage of Participants Scoring Device Tolerability as 3 or 4
Time frame: 60 minutes
Device Tolerability Subjective Feedback
Time frame: 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Exercise-Induced Laryngeal Obstruction
Not yet recruitingPhase 2
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Exercise-Induced Laryngeal Obstruction, Dyspnea During Activity
RecruitingObservational study
Swiss Paediatric Airway Cohort
Asthma, Wheezing
Recruiting
HelpILO - RCT on EILO Treatment
Exercise Induced Laryngeal Obstruction (EILO)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan Payne principal investigator
Liverpool University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous laryngoscopy during exercise test using the HALOS headgear in people with Exercise-Induced Laryngeal Obstruction, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Continuous Laryngoscopy During Exercise Tests (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.