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临床试验/NCT05376475
NCT05376475招募中不适用

Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders (SLeeP AID4): An Observational, In-Home, Single-Group, Feasibility Study

Shiphrah Biomedical Inc.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月6日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Maternal supine sleep position
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

SLeeP AID4 is a single-group, single-arm, Canada-wide, non-randomised, unblinded, in-home, observational study to prospectively collect and build a data set of natural sleep behaviour and physiology in maternal-fetal dyads (and bed partners, if applicable) in the third trimester of pregnancy in the home setting and subsequently investigate the feasibility of using computer vision technology (CVT) to monitor sleep during and across the third trimester of pregnancy in the home setting for research purposes by eliciting participants' attitudes toward CVT and training, validating, and testing a CVT model to accurately, unobtrusively, non-invasively, and objectively detect and quantify various sleep behaviours, disturbances, and disorders.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Healthy (see American Society of Anesthesiologists Physical Status [ASA-PS] classification; participant must be ASA-PS class II or lesser)
  • •Have a singleton pregnancy
  • •Be in the third trimester (gestational age between 28 weeks and 0 days through 40 weeks and 6 days, inclusive, by first-trimester ultrasound)
  • •Live in a home with a 2.4 GHz Wi-Fi network
  • •Sleep in a bed at night (i.e., not a La-Z-Boy chair or similar)
  • •Participant's Bed Partner (if applicable) Inclusion Criteria:
  • •Sleep in the same bed as the pregnant study participant.
  • •Healthy (see American Society of Anesthesiologists Physical Status [ASA-PS] classification; participant must be ASA-PS class II or lesser)
  • •Participant

排除标准

  • •Non-English speaking, reading, or writing
  • •ASA-PS class III or greater
  • •Participant's Bed Partner (if applicable) Exclusion Criteria:
  • •Non-English speaking, reading, or writing
  • •ASA-PS class III or greater

结局指标

主要结局

Maternal supine sleep position

时间窗: 4 nights (approximately 32 hours)

Average time per night, in minutes, spent supine while in bed as determined by manual review of infrared video.

次要结局

  • Maternal obstructive sleep apnea(4 nights (approximately 32 hours))
  • Bed partner sleep position(4 nights (approximately 32 hours))
  • Bed partner obstructive sleep apnea(4 nights (approximately 32 hours))
  • Maternal limb movements(4 nights (approximately 32 hours))
  • Bed partner limb movements(4 nights (approximately 32 hours))
  • Maternal restless legs syndrome(4 nights (approximately 32 hours))
  • Bed partner restless legs syndrome(4 nights (approximately 32 hours))
  • Maternal total sleep time (TST)(4 nights (approximately 32 hours))
  • Bed partner total sleep time (TST)(4 nights (approximately 32 hours))
  • Maternal time in bed (TIB)(4 nights (approximately 32 hours))
  • Bed partner time in bed (TIB)(4 nights (approximately 32 hours))
  • Maternal sleep efficiency(4 nights (approximately 32 hours))
  • Bed partner sleep efficiency(4 nights (approximately 32 hours))
  • Maternal rapid eye movement (REM) sleep duration(4 nights (approximately 32 hours))
  • Bed partner rapid eye movement (REM) sleep duration(4 nights (approximately 32 hours))
  • Maternal snoring(4 nights (approximately 32 hours))
  • Bed partner snoring(4 nights (approximately 32 hours))
  • Minimum maternal heart rate (HR)(4 nights (approximately 32 hours))
  • Minimum maternal respiration rate (RR)(4 nights (approximately 32 hours))
  • Minimum bed partner respiration rate (RR)(4 nights (approximately 32 hours))
  • Minimum bed partner heart rate (HR)(4 nights (approximately 32 hours))
  • Minimum maternal peripheral blood oxygen saturation (SpO2)(4 nights (approximately 32 hours))
  • Minimum bed partner peripheral blood oxygen saturation (SpO2)(4 nights (approximately 32 hours))
  • Maximum maternal heart rate (HR)(4 nights (approximately 32 hours))
  • Maximum bed partner heart rate (HR)(4 nights (approximately 32 hours))
  • Maximum maternal respiration rate (RR)(4 nights (approximately 32 hours))
  • Maximum bed partner respiration rate (RR)(4 nights (approximately 32 hours))
  • Maximum maternal peripheral blood oxygen saturation (SpO2)(4 nights (approximately 32 hours))
  • Maximum bed partner peripheral blood oxygen saturation (SpO2)(4 nights (approximately 32 hours))
  • Average maternal heart rate (HR)(4 nights (approximately 32 hours))
  • Average bed partner heart rate (HR)(4 nights (approximately 32 hours))
  • Average maternal respiration rate (RR)(4 nights (approximately 32 hours))
  • Average bed partner respiration rate (RR)(4 nights (approximately 32 hours))
  • Average maternal peripheral blood oxygen saturation (SpO2)(4 nights (approximately 32 hours))
  • Average bed partner peripheral blood oxygen saturation (SpO2)(4 nights (approximately 32 hours))
  • Maternal heart rate variability - root mean square of successive differences(4 nights (approximately 32 hours))
  • Fetal heart rate variability - root mean square of successive differences(4 nights (approximately 32 hours))
  • Maternal heart rate variability - standard deviation of NN intervals(4 nights (approximately 32 hours))
  • Fetal heart rate variability - standard deviation of NN intervals(4 nights (approximately 32 hours))
  • Maternal skin pressure distribution thorax(4 nights (approximately 32 hours))
  • Maternal skin pressure distribution abdomen(4 nights (approximately 32 hours))
  • Maternal skin pressure distribution pelvis(4 nights (approximately 32 hours))
  • Average fetal heart rate (FHR)(4 nights (approximately 32 hours))
  • Minimum fetal heart rate (FHR)(4 nights (approximately 32 hours))
  • Maximum fetal heart rate (FHR)(4 nights (approximately 32 hours))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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Sleep in Late Pregnancy - Artificial Intelligence... | 临床试验