Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies

Not Applicable

Completed

• Conditions: Exercise-Induced Laryngeal Obstruction
• Interventions: Device: Continuous laryngoscopy during exercise test using the HALOS headgear

• Registration Number: NCT05314478
• Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-24
• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-06
• Primary Completion: 2023-08-25
• Study Completion: 2023-08-25
• Status Verified: 2023-10
• Results First Submitted: 2024-01-23
• Results First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-28
• Results First Posted: 2024-11-08
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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:

  • 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
  • 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	Continuous laryngoscopy during exercise test using the HALOS headgear	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Liverpool University Hospitals Nhs Foundation Trust; 🇬🇧 Liverpool, Merseyside, United Kingdom