Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies (HALOS)

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.

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 Overview

• Status: Completed
• Conditions: Exercise-Induced Laryngeal Obstruction
• Intervention / Treatment: Device: Continuous laryngoscopy during exercise test using the HALOS headgear

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L7 8XP
      • Liverpool University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	60 minutes
Device Usability Subjective Feedback	Focussing on any clinician-reported concerns regarding set-up, operation and cleaning.	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).	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.	60 minutes

Collaborators and Investigators

• Sponsor: Liverpool University Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Tristan Payne, Liverpool University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Actual): August 25, 2023
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Laryngoscopy; Exercise-Induced; Laryngeal Obstruction; Headgear
• Other Study ID Numbers: SP0707

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No