Baby Breathing Monitoring @Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Can we measure baby behavior and physiology by camera and / or wearable?
研究概览
简要总结
To give reassurance to parents, Philips would like to add algorithms to the NightOwl baby monitor to be able to measure baby behavior and physiology.
In this study, the investigators aim to investigate the applicability of in-house breathing algorithms, and to develop algorithms, for babies sleeping in a home setting.
The data collection will be divided in several sub-studies, either e.g. matching different development steps in the development of the algorithm or focusing on a specific baby population (e.g. specific age range). In general, babies will be monitored (audio, video, activity) for 24 -48 hours under their habitual sleeping conditions.
Step 1: 3 full data sets will be recorded of babies in bed aged 3 weeks to about 3-4 months, who are not able to turn over yet. Data will be analyzed and study set-up will be checked. Parents will be asked to keep a baby sleep diary and a questionnaire will be filled in at the start, with questions regarding the sleep behavior of their child. At the end, parents will be asked to fill in a questionnaire with sleep-related and feedback questions.
In step 2, 5 full data sets will be collected following the same procedure as step 1.
In step 3 12 full data sets will be collected following the same procedure as step 1.
After each step, the study setup including the algorithms, will be reviewed based on the obtained data. All modifications to this protocol will be submitted as amendments.
After step 1 and 2, the Mother and Child Care Business unit of Philips and other relevant stakeholders will be updated on the progress and findings by means of a (short) meeting and PowerPoint slides.
After step 3, a report will be written. The PowerPoint slides shared after Step 1 and 2 will be incorporated in this report.
详细描述
Procedures Phone call
During the Phone call the investigators will:
- explain the study setup
- explain the exclusion and inclusion criteria. The criteria will not be verified until visit 1.
- if the parents or caregivers agree, an appointment will be made for visit 1
- Home visit 1 - about 45 min
During the first home visit the investigators will:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Weeks 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents or caregivers :
- •Have a baby aged >3 weeks to ~3-4 months (who is not yet able to role over; see exclusion criteria);
- •Have a baby who sleeps in its own bed (i.e. different sleeping surface than parents; same room is allowed);
- •Live in the Netherlands;.
- •Are able to speak and read Dutch or English.
排除标准
- •Parents or caregivers
- •with a baby who can already roll over (belly to back and back to belly);
- •with a baby who is under supervision of an HCP because of health, feeding or developmental problems ;
- •are unwilling or unable to provide informed consent on behalf of themselves, their baby and siblings;
- •are unwilling or unable to comply with the study requirements;
- •do not give permission to use their, or that of potential siblings, audio-video image data recorded during the study as described in the information letter and privacy notice;
- •are not able to fill in the questionnaires and baby sleep diary.
结局指标
主要结局
Can we measure baby behavior and physiology by camera and / or wearable?
时间窗: through study completion, up to 1 year
次要结局
- Can we derive sleep stages from the data?(up to 3 months)
- Can we distinguish the baby (audio & movement) from other people near the bed (i.e. parents and/or siblings)?(up to 3 months)
- Can we detect and / or interpret baby crying?(up to 3 months)
- Can we measure breathing at all by camera when the baby is in bed?(up to 3 months)
- Can we measure when the baby is in and out of bed?(up to 3 months)