Clinical trial NCT05314478: Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies
Official title: Safe and Effective Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies (HALOS) - a Device Development Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise-Induced Laryngeal Obstruction
Keywords: Laryngoscopy
Exercise-Induced
Laryngeal Obstruction
Headgear
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2022-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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).
* 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.

Primary outcomes:
measure: Percentage of Participants With Continuous Laryngoscopy During Exercise Tests
timeFrame: 30 minutes
Secondary outcomes:
measure: Percentage of Participants With Device Usability Rating of 4 or 5
timeFrame: 60 minutes
measure: Device Usability Subjective Feedback
timeFrame: 60 minutes
measure: Percentage of Participants Scoring Device Tolerability as 3 or 4
timeFrame: 60 minutes
measure: Device Tolerability Subjective Feedback
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals Nhs Foundation Trust
state: Merseyside
Study officials:
affiliation: Liverpool University Hospitals NHS Foundation Trust
name: Tristan Payne
role: PRINCIPAL_INVESTIGATOR
References: