Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Women
Comparison of Pulse Wave and Blood Pressure Parameters Before, During and After Exercise Ergometry in Healthy Female Subjects - a Randomized, Controlled, Single-blind Study
The objective of this randomized, controlled single blind study is to compare pulse wave and blood pressure measurements before, during and after exercise ergometry in healthy female subjects.
研究概览
详细说明
In a randomized single-blind study design the investigators explore how well blood pressure parameters calculated using a Pulse Transit Time-based method (device: SOMNOtouchTM RESP) match blood pressure parameters measured by a classic upper arm blood pressure cuff (BOSO-TM-2430 ) under standardized load conditions (ergometry).
In 30 healthy female subjects (age 18 - 40 years), cardiovascular parameters before, during and after a standardized load on a bicycle ergometer (half-lying position) are recorded with three different devices (BOSO-TM-2430 versus SOMNOtouchTM RESP versus GeTeMed Vitaguard 3100) and compared.
Primary outcome is the difference of the systolic blood pressure values between the devices BOSO-TM-2430 versus SOMNOtouchTM RESP during the three phases.
The BOSO-TM-2430 blood pressure cuff is applied randomized to the arm with the previously determined higher or lower systolic blood pressure mean difference. The subjects are blinded to the results of the measurements during ergometry.
After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest period. Measurements are taken every two minutes with the BOSO-TM-2430; data acquisition with the SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 devices takes place continuously over a total duration of 72 minutes.
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Baden Württemberg
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Filderstadt、Baden Württemberg、德国、70794
- Arcim Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Signed informed consent
- Healthy at the time of the examinations
- Inconspicuous anamnesis regarding cardiovascular diseases and bronchial asthma
- resting heart rate 50 to 100 beats per minute
- Normal blood pressure or appropriately treated and controlled hypertension (systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg)
Exclusion Criteria:
- Acute or chronic (especially cardiovascular) diseases, including cardiac arrhythmia and vegetative regulatory disorders (recorded via anamnesis)
- Taking allopathic medication: digitalis, beta blockers, antiarrhythmics
- Bronchial asthma (recorded by anamnesis)
- Alcohol abuse
- Heart diseases NYHA class IV
- Blood pressure side difference ≥ 10mmHg
- Fever (> 37,5°C)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Higher Blood Pressure
BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure.
Intervention: Ergometry H
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After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period. BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure (reference parameter). SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined lower systolic blood pressure. |
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实验性的：Lower Blood Pressure
BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure.
Intervention: Ergometry L
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After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period. BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure (reference parameter). SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined higher systolic blood pressure. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference of the systolic blood pressure
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Primary outcome is the difference of the systolic blood pressure values between the devices BOSO-TM-2430 versus SOMNOtouchTM RESP during the three phases
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diastolic Blood Pressure (SOMNOtouchTM RESP)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Diastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Mean Arterial Blood Pressure (SOMNOtouchTM RESP)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Mean Arterial Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Pulse Pressure (SOMNOtouchTM RESP)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Heartrate (SOMNOtouchTM RESP)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Oxygen saturation (SpO2, SOMNOtouchTM RESP)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Pulse-Transit-Time (PTT, SOMNOtouchTM RESP)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Systolic Blood Pressure measured with the device BOSO-TM-2430
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Systolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Diastolic Blood Pressure measured with the device BOSO-TM-2430
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
Diastolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Mean Arterial Blood Pressure measured with the device BOSO-TM-2430
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
Mean Arterial Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Pulse Pressure measured with the device BOSO-TM-2430
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Pulse Pressure (mmHg) measured with the BOSO-TM-2430 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Heartrate measured with the device BOSO-TM-2430
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Heartrate (beats per minute, bpm) measured with the BOSO-TM-2430 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Pulse Transit Time (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Pulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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Perfusion Index (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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SlopeInW1 (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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SlopeInW1 measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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SlopeInW2 (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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SlopeInW2 measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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SlopeInW3 (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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SlopeInW3 measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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SlopeInW4 (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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SlopeInW4 measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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StiffnessIndex (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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StiffnessIndex measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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ReflectionIndex (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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ReflectionIndex measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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TimeTX (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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TimeTY (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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QuotTYTX (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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QuotTYTX measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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AreaAX (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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AreaAX measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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AreaAY (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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AreaAY measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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QuotAYAX (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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QuotAYAX measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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AreaAV (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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AreaAV measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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AreaAW (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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AreaAW measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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QuotAWAV (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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QuotAWAV measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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QuotTVTW (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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QuotTVTW measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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TimeTV (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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TimeTW (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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MinT1 (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the first peak
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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MinT2 (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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MaxT1 (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the first peak
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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MaxT2 (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the second peak
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
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QuotHRRespRate (GeTeMed Vitaguard 3100)
大体时间：Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device
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Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Jan Vagedes, MD、ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年1月29日
初级完成 (实际的)
2019年5月17日
研究完成 (实际的)
2019年5月17日
研究注册日期
首次提交
2019年1月2日
首先提交符合 QC 标准的
2019年1月3日
首次发布 (实际的)
2019年1月4日
研究记录更新
最后更新发布 (实际的)
2019年8月7日
上次提交的符合 QC 标准的更新
2019年8月6日
最后验证
2019年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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