Safe and Effective Headgear Accessory for Exercise-Induced Laryngeal Obstruction Studies (HALOS) - a Device Development Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Continuous Laryngoscopy During Exercise Tests
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage of Participants With Continuous Laryngoscopy During Exercise Tests
时间窗: 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.
次要结局
- 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)