Skip to main content
OpenTrials
Completed

NCT Number: NCT05314478

Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Exercise-Induced Laryngeal Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool University Hospitals Nhs Foundation Trust

Liverpool, Merseyside, L7 8XP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous laryngoscopy during exercise test using the HALOS headgear

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of Participants With Device Usability Rating of 4 or 5

    Time frame: 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).

  2. Device Usability Subjective Feedback

    Time frame: 60 minutes

    Focussing on any clinician-reported concerns regarding set-up, operation and cleaning.

  3. Percentage of Participants Scoring Device Tolerability as 3 or 4

    Time frame: 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).

  4. Device Tolerability Subjective Feedback

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust

Other Gov

Registry information

Official study title

Safe and Effective Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies (HALOS) - a Device Development Study

Acronym: HALOS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2022
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.