Status:
COMPLETED
Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies
Lead Sponsor:
Liverpool University Hospitals NHS Foundation Trust
Conditions:
Exercise-Induced Laryngeal Obstruction
Eligibility:
All Genders
18+ years
Phase:
NA
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 Laryngosc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05314478
Start Date
March 24 2022
End Date
August 25 2023
Last Update
November 8 2024
Active Locations (1)
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1
Liverpool University Hospitals Nhs Foundation Trust
Liverpool, Merseyside, United Kingdom, L7 8XP