NCT03948152已完成不适用
A Study to Determine Clinician and Patient Preferences Towards Interface Products Recommended by the 3D Mask Advice Tool
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 10
- 主要终点
- Proportion of participants requiring one or more mask re-fits
研究概览
简要总结
Enrolled Naïve participants will be randomized to one of two arms, the investigational or control arm. Once randomized the institutions will fit the participant with the procedures outlined in the protocol. Each participant will be required to trial the mask for a period of 90 days. Any Unscheduled Visits or Calls that occur during the participants 90 days documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Volunteers (ages 21-85)
- •Willing and able to provide informed consent
- •Able to follow instructions
- •Able to read and speak in English as their primary language
- •Currently diagnosed with Sleep Apnea through an in-lab sleep (polysomnography (PSG)) or home sleep testing, but has not started therapy and/or been fit with a mask.
排除标准
- •Pre-existing conditions such as bullous lung disease, pathologically low blood pressure, bypassed upper airway, pneumothorax, pneumocephalus, cerebral spinal fluid (CSF) leaks, cribriform plate abnormalities, and prior history of head trauma that has resulted in current cognitive dysfunction.
- •Prescribed an Adaptive Servo Ventilation (ASV) device
- •The presence of physical or mental limitations that would limit the ability to test the mask.
- •Obstructive Sleep Apnea (OSA) diagnosis achieved through a split night sleep study
- •Known allergy to silicone
- •Unique facial features (i.e. deformities of the face and/or head, piercings, etc) that could interfere with the use of masks.
- •Employee of Philips or spouse of a Philips employee
- •Currently participating in another interventional research study or planned participation in another interventional research study during the trial period (by self-report)
- •Surgery involving the eyes, ears, nose, sinuses, or upper airway within the last 90 days.
- •Planned surgical procedures involving the head, neck, face (eyes, ears, nose), or lung during the trial period.
- •Uncontrolled or poorly managed gastroesophageal reflux
- •Impaired cough reflex
- •Untreated or symptomatic hiatal hernia
- •Untreated glaucoma
- •Untreated chronic dry eyes
- •Unable to remove the sleep apnea mask without the assistance of others
- •Use of prescription drugs that induce vomiting
结局指标
主要结局
Proportion of participants requiring one or more mask re-fits
时间窗: 90 days
Proportion of participants in each arm requiring one or more mask re-fits.
次要结局
- Number of sleep clinic or sleep center callbacks related to mask fitting issues(90 days)
- The amount of time spent on these calls to resolve mask issues(90 days)
- Number of unplanned visits to adjust current mask or fit with another masks(90 days)
- Adherence to CPAP therapy(90 days)
- Number of masks tried during the initial fitting visit(90 days)
- Amount of time to fit each mask(90 days)
- Duration of the unplanned visits(90 days)
- Number of masks tried after going home with the first mask(90 days)
- Mask leak for chosen masks(90 days)
- Subjective preference rated by patients(90 days)
- Subjective preference rated by clinicians(90 days)
研究者
研究点 (10)
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