Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies

NCT05314478 | Completed Results

• 1 other identifier: SP0707
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise-Induced Laryngeal Obstruction

Keywords

Laryngoscopy; Exercise-Induced; Laryngeal Obstruction; Headgear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of Participants With Device Usability Rating of 4 or 5

  60 minutes

• Device Usability Subjective Feedback

  60 minutes

• Percentage of Participants Scoring Device Tolerability as 3 or 4

  60 minutes

• Device Tolerability Subjective Feedback

  60 minutes

Study Arms (1)

Participants

EXPERIMENTAL

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

Interventions

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: 1. The headgear is prepared for use. 2. The headgear is fitted onto the participant's head. 3. The endoscope is inserted into the participant. 4. The endoscope is fitted onto the headgear. 5. The CLE test is carried out. 6. The endoscope is removed from the headgear. 7. The endoscope is removed from the participant. 8. The headgear is removed from the participant. 9. The headgear is cleaned and stored.

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Liverpool University Hospitals Nhs Foundation Trust

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Results Point of Contact

• Title: Dr Tristan Payne
• Organization: Liverpool University Hospitals NHS Foundation Trust

tristan.payne@liverpoolft.nhs.uk

01517064553

Study Officials

• Tristan Payne

  Liverpool University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 6, 2022
• Study Start: March 24, 2022
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2023-10

Locations

GB (1)