Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comparison of the algorithm efficacy (AHI) to a clinically relevant data
研究概览
简要总结
This study aims to assess the effectiveness of an investigational algorithm in the treatment of obstructive sleep apnea.
详细描述
This is a blind, randomized cross over (or single arm depending on phase) study aiming to show that the new algorithm is efficacious in the treatment of obstructive sleep apnea (OSA). Furthermore, it allows for the comparison of relevant objective data parameters from the device and subjective outcomes in comparison to an established algorithm.
This study is planned in two phases. Phase 1 aims to gain confidence that the algorithm is functioning as intended, and allow for minor modifications to be made to the software before proceeding to Phase 2.
Phase 2 aims to assess the performance of the algorithm in a broader range of participants to capture data and subjective feedback comparing the users experience between the new algorithm and the control algorithm.
After the conclusion of phase 1 and 2, an optional extended trial period will be offered to participants who indicate that the experience on the investigational device was satisfactory and would like to continue using the algorithm will be included in an optional extended trial period.
The study will be conducted in the home environment. Participants who met the inclusion/exclusion criteria will be contacted. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit. In addition, subjects may be asked if they are willing to wear a wearable during both day and night (unless charging) for the duration of the study iteration. The wearable will be a commercially available wellness wearable that collects data to provide information about sleep and activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single (Participant)
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
- •Participants willing to give written informed consent.
- •Participants who can read and comprehend English.
- •Participants who ≥ 18 years of age
- •Participants who have been using a ResMed AirSense 10 or 11 device.
- •Participants currently using AutoSet (APAP) mode.
- •Participants being established on PAP therapy for the treatment of OSA for approximately >3 months.
- •Participants who can participate in the study for up to 8 weeks.
排除标准
- •Participants using Bilevel flow generators.
- •Participants using CPAP, AutoSet for Her
- •Participants who are or may be pregnant.
- •Participants 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.
- •Participants believed to be unsuitable for inclusion by the researcher.
- •Participants who are currently enrolled in other medical clinical studies
研究组 & 干预措施
Investigational algorithm
The participants will trial the investigational algorithm and the control algorithm in a randomized order. Each will be used for up to 4 weeks in the home environment in place of their own device/therapy. The study device will be set up to align with the majority of the participants current therapy settings.
干预措施: Investigational algorithm (Device)
Control algorithm
The participants will trial the investigational algorithm and the control algorithm in a randomized order. Each will be used for up to 4 weeks in the home environment in place of their own device/therapy. The study device will be set up to align with the majority of the participants current therapy settings.
干预措施: Control algorithm (Device)
结局指标
主要结局
Comparison of the algorithm efficacy (AHI) to a clinically relevant data
时间窗: 8 weeks
The mean residual AHI of the investigational algorithm will be compared against an excepted clinical benchmark of 5 using a one sample t test.
次要结局
- Secondary endpoint: Device usage(From enrolment to the end of each study arm (up to 8 weeks))
- Secondary endpoint: Leak(From enrollment to the end of each study arm (up to 8 weeks))
- Secondary endpoint: Pressure(From enrolment to the end of each study arm (up to 8 weeks))
- Secondary endpoint: Subjective scores(From enrolment to the end of each study arm (up to 8 weeks))
- Secondary endpoint: Device usage(From enrolment to the end of each study arm (up to 8 weeks))
- Secondary endpoint: Leak(From enrollment to the end of each study arm (up to 8 weeks))
- Secondary endpoint: Pressure(From enrolment to the end of each study arm (up to 8 weeks))
- Secondary endpoint: Subjective scores(From enrolment to the end of each study arm (up to 8 weeks))
- Wearable data - Sleep metrics(From enrolment to the end of each study arm (up to 8 weeks))
- Wearable data - Activity Metrics(From enrolment to the end of each study arm (up to 8 weeks))