Evaluating the Efficacy of Positive Airway Pressure Therapy for Treating Obstructive Sleep Apnea in the Home Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Usability
研究概览
简要总结
This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites). Each participant will use the investigational PAP device with their own mask for a period of up to 7 nights and will complete a series of questionnaires upon completion. The study will evaluate the usability and efficacy of the investigational device in the intended use environment by the intended use population.
详细描述
A new PAP device has been developed by ResMed which includes an improved humidification system, a new user interface and optimized workflows. This study will assess the efficacy and usability of the new PAP device in an OSA population.
This is a prospective, open-label, single arm study, multi-site study to assess the usability and efficacy of investigational device in the home environment.
Recruitment Recruitment will be done via phone calls/ SMS messages/ emails. Participants will be explained the details of the study and those who wish to take part will be invited to a ResMed clinic or selected site for the first study visit (As detailed in section 7).
Visit 1 Participants will provide written informed consent (as per section 6.1). If eligible, baseline participant demographics will be collected. Participants will be shown the investigation device. If the participant is happy to proceed the investigational device will be set-up to be exactly the same as their current CPAP device, and the participant will take it home to use in place of their own device.
Visit 2 At the conclusion of the 7 nights of use, the participant will be asked to fill in a questionnaire documenting their experience with the investigational device. The participant will return all study equipment to the researcher. The questionnaires will be reviewed. This concludes the participation in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Patients willing to give written informed consent
- •Patients who can read and comprehend English
- •Patients who ≥ 18 years of age
- •Patients being established on PAP therapy for the treatment of OSA for ≥ 6 months
- •Patients currently using AirSense10 (as their primary device)
- •Patients currently using an appropriate mask system (AirFit F20, AirFit P10, AirFit N20, AirFit N30i, AirFit F30i or AirFit P30i)
- •Patients who can trial the investigational device for up to 7 nights
- •Patients who have been compliant to therapy (average of ≥4 hours of usage) for the previous 7 nights of use* *the most recent consecutive 7 nights within the last 30 days
排除标准
- •Patients using Bilevel flow generators
- •Patients who are or may be pregnant
- •Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
- •Patients believed to be unsuitable for inclusion by the researcher
- •Patients who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable)
- •Patients using supplemental oxygen
结局指标
主要结局
Usability
时间窗: 1 week
Subjective ratings of the Usability of the Pacific device after using it in the home environment for up to 7 nights. Ratings will be collected using an 11 point Likert Scale where a score of 10 is considered very favorable, and a score of 0 is very unfavorable.
次要结局
- Apnea Hypopnea Index (AHI)(1 week)
- Usage-Positive Airway Pressure (PAP) Device parameters(1 week)
- Leak-Positive Airway Pressure (PAP) Device parameters(1 week)
- Pressure-Positive Airway Pressure (PAP) Device parameters(1 week)
- Acoustic Signals(1 week)