Development of Advanced Leak Detection Technologies for Positive Airway Pressure Devices Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Acoustic signals
研究概览
简要总结
This study will take between 1-2 months (with first patient first visit to last patient last visit). Each participant will use the supplied PAP device and mask for a period of up to 14 nights. Participants will complete a series of questionnaires. The study will collect data to support the development of an advance leak detection technology.
详细描述
The investigation device is designed to collect leak patterns which will be analysed to develop an advanced leak detection technology to help users/patients to troubleshhot therapy issues.
This will be a multi-centre, multiphase, single arm study. The study will be conducted in the home environment.
Recruitment Recruitment will be done via phone calls/ SMS messages/ emails. Participants will be explained the details of the trial and those who wish to take part will be invited to ResMed for the first study visit.
Visit 1 Participants will provide written informed consent. If eligible, baseline participant demographics will be collected. Participants will be shown the investigation equipment. If the participant is happy to proceed, the therapy and comfort settings of the trial PAP device will be set-up to match their current PAP device and a mask similar to the participant's current mask will be provided to take home and be use in place of their own equipment.
Visit 2 After completing 7 days of the trial participants will return to the ResMed. The researcher will review the questionnaire and data quality with the participant.
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 120 Years（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 have a possible risk of mouth leak.
- •Patients willing to give written consent for the recording of full band audio during sleep session.
- •Patients who are willing to not wearing chin strap for a period of nights during study, if they currently use one.
- •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 an appropriate mask system, AirFit P10, AirFit N20, AirFit N20, AirFit N30i (2 check version is correct) or similar mask (non-full face).
- •Patients who can trial the investigational device for up to 14 nights
- •Patients who have been compliant to therapy for the previous 7 nights of use.
排除标准
- •Patients willing to give written informed consent.
- •Patients who have a possible risk of mouth leak.
- •Patients willing to give written consent for the recording of full band audio during sleep session.
- •Patients who are willing to not wearing chin strap for a period of nights during study, if they currently use one.
- •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 an appropriate mask system, AirFit P10, AirFit N20, AirFit N20, AirFit N30i (2 check version is correct) or similar mask (non-full face).
- •Patients who can trial the investigational device for up to 14 nights
- •Patients who have been compliant to therapy for the previous 7 nights of use.
结局指标
主要结局
Acoustic signals
时间窗: 2 Months
Cross-correlation of acoustic signals recorded from the patient environment and the objective leak data recorded by the investigational Positive Airway Pressure Device.
次要结局
未报告次要终点