An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy
试验速览
- 阶段
- 不适用
- 发起方
- ResMed
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Identify any failures when using the Drive app for users of CPAP therapy
研究概览
简要总结
The purpose of this study is to evaluate the usability and suitability of the Drive app (app under test) to measure sleep parameters during CPAP use.
This is a prospective, non-randomized, single arm exploratory study without blinding.
Current users of CPAP therapy will be recruited for this study and will be provided with a smartphone (app under test installed) and a non-contact motion sensor in their home environment. These devices will measure sleep metrics such as sleep stages and breathing metrics that may be associated with sleep disordered breathing. Usage and setup instructions will be provided for the study.
Participants will contribute up to 7 overnight recordings in the home environment and will complete daily questionnaires detailing their experience.
The study may be completed in two distinct phases, with an analysis performed after each phase. Each phase is expected to last up to six weeks with the overall study duration taking up to 12 months.
详细描述
The study may be completed in two distinct phases, with an analysis performed after each phase.
Phase 1 (Exploratory): A minimum of 10 and up to 12 participants will be recruited to identify any issues in using the app when used in conjunction with CPAP therapy (e.g. missed signals, inappropriate classification of breathing signals).
Phase 2 (Iterative Updates): Where changes to the algorithm or user interface are required, an additional 30 and up to 35 participants may be tested to provide design confidence. Conversely, if substantial issues are experienced and the time and effort required to address the issues is sufficiently large, the study may terminate before completion of phase 2.
Each phase is expected to last up to six weeks with the overall study duration taking up to 12 months.
Participants will be required to visit ResMed twice. The first visit will involve briefing of the study, consent form signatures, briefing on trial equipment and setup/usage instructions. The second (last) visit will involve going through the daily questionnaires with participants, collecting trial equipment and providing reimbursement for 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
- Device Feasibility
- 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
- •Participants willing to give written informed consent
- •Participants who can read and comprehend English
- •Participants who ≥ 18 years of age
- •Participants established on CPAP therapy for the treatment of OSA for ≥ 6 months
- •Participants who are able to set up the trial devices (ideally on a bedside table) with the following criteria:
- •Trial devices must be 10 cm higher than the mattress
- •Approx. 40 cm from the person's chest in bed
- •Participants that have access to WI-FI in their home environment
- •Participants who can trial the device for up to 7 nights
- •*Participants who have been compliant (average of ≥4 hours of usage) to therapy for up to 7 nights of use
- •Note: the most recent consecutive 7 nights within the last 30 days
排除标准
- •Participants using Bilevel flow generators
- •Participants who are or may be pregnant, breastfeeding or within 6 weeks postpartum (which are known to cause significant sleep disruption)
- •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 using one of the following devices or Apps during the research period, or any other sleep tracking devices: SPlus, SleepScore app, SleepScore Max.
- •Note: If the participant uses the devices or apps above and they agree to delete/not use them during study period, they can be included in the study.
结局指标
主要结局
Identify any failures when using the Drive app for users of CPAP therapy
时间窗: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
This will be based on: 1. Subjective data from daily questionnaires sent out to participants 2. Comparison between Drive app data with the non contact motion sensor and CPAP data The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire. Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.
次要结局
- Compare subjective sleep quality data with data generated on the app.(12 months (includes Phase 1 and Phase 2 and interim data analysis))
- Evaluate usability of the Drive app(12 months (includes Phase 1 and Phase 2 and interim data analysis))
- Compare the Drive app sleep data to data from the reference devices.(12 months (includes Phase 1 and Phase 2 and interim data analysis))