Validation Study of a Patch-based PSG System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 14
- 主要终点
- EMG left
研究概览
简要总结
This study is a study that qualifies as "other clinical investigation" under Art. 82 MDR and §47 Abs. 3 MPDG with a CE-marked device that aims to demonstrate that the physiological signals from the Onera STS system are substantially equivalent to physiological systems recorded by traditional PSG systems. Furthermore, the study aims to identify the proportion of users who can successfully perform an overnight Onera STS study in an unsupervised home setting. The Onera STS will be used within its approved indication, and the study participants will not be subjected to additional invasive or burdensome procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •18 years and older
- •Either referral for a suspected sleep disorder requiring a sleep diagnostic study, or,
- •An already diagnosed sleep disorder requiring a planned follow-up PSG.
排除标准
- •Inability to provide informed consent
- •History of allergic reactions to adhesives or hydrogels or a family history of adhesive skin allergies
- •Severe skin condition at sites of patch administration such as wounds, burns or on any damaged skin
- •Has an implanted cardiac stimulator or diaphragmatic pacer
- •Has an anatomical abnormality that, in the opinion of the Principal Investigator, makes the subject ineligible for inclusion
- •Will be exposed to high-frequency surgical equipment, near strong magnetic fields or with devices such as MRIs, external cardiac stimulators during their use of the Onera device
结局指标
主要结局
EMG left
时间窗: 1 year
Electromyogram (EMG) is measured on the left side. Here, electrical activity of the muscle is measured with an electrode and expressed in microvolt\[uV\].
EEG right
时间窗: 1 year
Electroencephalogram (EEG) is measured on the right side. Here, electrical activity of the brain is measured with an electrode and expressed in microvolt\[uV\].
SpO2
时间窗: 1 year
Oxygen Saturation (SpO2) is derived from red and infrared Photoplethysmography (PPG) which is measured on the forehead with a reflective pulse oximetry sensor.
ECG
时间窗: 1 year
Electrocardiogram (ECG) is measured on the chest. Here, electrical activity of the heart is measured with an electrode and expressed in microvolt\[mV\].
EMG right
时间窗: 1 year
Electromyogram (EMG) is measured on the right side. Here, electrical activity of the muscle is measured with an electrode and expressed in microvolt\[uV\].
BioZ Flow
时间窗: 1 year
Respiratory Flow (BioZ Flow) is derived from the bioimpedance which is measured on the chest with an electrode (expressed: \[a.u.\]).
EEG left
时间窗: 1 year
Electroencephalogram (EEG) is measured on the left side. Here, electrical activity of the brain is measured with an electrode and expressed in microvolt\[uV\].
BioZ Effort
时间窗: 1 year
Respiratory Effort (BioZ Effort) is derived from the bioimpedance which is measured on the chest with an electrode (expressed: \[a.u.\]).
Nasal Cannula Flow
时间窗: 1 year
The Nasal Cannula Flow is measured on the belly using a cannula (expressed: \[mmH2O\]).
EOG left
时间窗: 1 year
Electrooculogram (EOG) is measured on the left side. Here, electrical activity of the eye is measured with an electrode and expressed in microvolt\[uV\].
EOG right
时间窗: 1 year
Electrooculogram (EOG) is measured on the right side. Here, electrical activity of the eye is measured with an electrode and expressed in microvolt\[uV\].
Body Position
时间窗: 1 year
The body Position is derived from the accelerometer data of the x, y, and z axis, which is measured on the chest and expressed in degrees\[deg\].
Activity
时间窗: 1 year
The activity is derived from the accelerometer data of the x, y, and z axis, which is measured on the chest and expressed in the gravitational force equivalent\[g\].
Snoring
时间窗: 1 year
Snoring is measured with the microphone imbedded in the sensor on the chest and expressed in Decibel\[dB\].
EMG Leg
时间窗: 1 year
Electromyogram (EMG) is measured on the lower leg. Here, electrical activity of the muscle is measured with an electrode and expressed in microvolt\[mV\].
次要结局
- Wake Time(1 year)
- Time in REM(1 year)
- Total Sleep Time(1 year)
- Time In Bed(1 year)
- SOL(1 year)
- REM Onset Latency(1 year)
- WASO(1 year)
- ODI(1 year)
- Time in N1(1 year)
- REM(1 year)
- AI(1 year)
- Time in N2(1 year)
- Time in NREM(1 year)
- SpO2(1 year)
- Time in N3(1 year)
- NREM(1 year)
- AHI(1 year)
- HR(1 year)
- Set-up Time PSG (not applicable for application in unsupervised home setting)(1 year)