Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies

NCT ID: NCT05314478

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2023-08-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Continuous laryngoscopy during exercise test using the HALOS headgear

Intervention Type: 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.

Interventions

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:

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.

Intervention Type: DEVICE

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).

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tristan Payne

Role: PRINCIPAL_INVESTIGATOR

Liverpool University Hospitals NHS Foundation Trust

Locations

Liverpool University Hospitals Nhs Foundation Trust

Liverpool, Merseyside, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SP0707

Identifier Type: -

Identifier Source: org_study_id