- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790722
Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Men
Comparison of Pulse Wave and Blood Pressure Parameters Before, During and After Exercise Ergometry in Healthy Male Subjects - a Randomized, Controlled, Single-blind Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 (Mobil-O-Graph® PWA) under standardized load conditions (ergometry).
In 30 healthy male 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 (Mobil-O-Graph® PWA versus SOMNOtouchTM RESP versus GeTeMed Vitaguard 3100) and compared.
Primary outcome is the difference of the systolic blood pressure values between the devices Mobil-O-Graph® PWA versus SOMNOtouchTM RESP during the three phases.
The Mobil-O-Graph® PWA 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 Mobil-O-Graph® PWA; data acquisition with the SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 devices takes place continuously over a total duration of 72 minutes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Baden Württemberg
-
Filderstadt, Baden Württemberg, Germany, 70794
- Arcim Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Higher Blood Pressure
Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure.
Intervention: Ergometry H
|
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. Mobil-O-Graph PWA 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. |
Experimental: Lower Blood Pressure
Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure.
Intervention: Ergometry L
|
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. Mobil-O-Graph PWA 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of the systolic blood pressure
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Primary outcome is the difference of the systolic blood pressure values between the devices Mobil-O-Graph® PWA versus SOMNOtouchTM RESP during the three phases
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diastolic Blood Pressure (SOMNOtouchTM RESP)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Diastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Mean Arterial Blood Pressure (SOMNOtouchTM RESP)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Mean Arterial Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Pulse Pressure (SOMNOtouchTM RESP)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Heartrate (SOMNOtouchTM RESP)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Oxygen saturation (SpO2, SOMNOtouchTM RESP)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Pulse-Transit-Time (PTT, SOMNOtouchTM RESP)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Systolic Blood Pressure measured with the device Mobil-O-Graph® PWA
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Systolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Diastolic Blood Pressure measured with the device Mobil-O-Graph® PWA
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Diastolic Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Mean Arterial Blood Pressure measured with the device Mobil-O-Graph® PWA
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Mean Arterial Blood Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Pulse Pressure measured with the device Mobil-O-Graph® PWA
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Pulse Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Heartrate (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Heartrate (beats per minute, bpm) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Puls Pressure Amplification (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Puls Pressure Amplification measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Stroke Volume (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Stroke Volume (ml) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Cardiac output (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Cardiac output (l/min) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Vascular Resistance (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Vascular Resistance (s*mmHg/ml) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Cardiac Index (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Cardiac Index (l/min*1/m2) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Augmentation Pressure (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Augmentation Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Reflection Coefficient (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Reflection Coefficient (%) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Pulse Wave Velocity (PWV) (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Pulse Wave Velocity (PWV, m/s) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Systole Time (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Systole Time (s) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Tmax-forward (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Tmax-forward (s) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Tmax-backward (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Tmax-backward (s) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Forward Pressure (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Forward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Backward Pressure (Mobil-O-Graph® PWA)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Backward Pressure (mmHg) measured with the Mobil-O-Graph® PWA device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Pulse Transit Time (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Pulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Perfusion Index (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
SlopeInW1 (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
SlopeInW1 measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
SlopeInW2 (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
SlopeInW2 measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
SlopeInW3 (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
SlopeInW3 measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
SlopeInW4 (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
SlopeInW4 measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
StiffnessIndex (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
StiffnessIndex measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
ReflectionIndex (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
ReflectionIndex measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
TimeTX (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
TimeTY (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
QuotTYTX (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
QuotTYTX measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
AreaAX (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
AreaAX measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
AreaAY (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
AreaAY measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
QuotAYAX (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
QuotAYAX measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
AreaAV (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
AreaAV measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
AreaAW (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
AreaAW measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
QuotAWAV (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
QuotAWAV measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
QuotTVTW (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
QuotTVTW measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
TimeTV (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
TimeTW (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
MinT1 (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the first peak
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
MinT2 (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
MaxT1 (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the first peak
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
MaxT2 (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the second peak
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
QuotHRRespRate (GeTeMed Vitaguard 3100)
Time Frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 min (Mobil-O-Graph©PWA) for a total duration of 72 min
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Jan Vagedes, MD, ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ERG_02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Male Subjects
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Hoffmann-La RocheCompleted
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Innovent Biologics (Suzhou) Co. Ltd.CompletedHealthy Male SubjectsChina
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Completed
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CelltrionCompletedHealthy Male SubjectsAustralia
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Jiangsu HengRui Medicine Co., Ltd.CompletedHealthy Male SubjectsChina
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JHL Biotech, Inc.CompletedHealthy Male SubjectsBulgaria
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PfizerCompletedHealthy Male SubjectsNetherlands
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Hanlim Pharm. Co., Ltd.CompletedHealthy Male SubjectsKorea, Republic of
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Hanlim Pharm. Co., Ltd.CompletedHealthy Male SubjectsKorea, Republic of
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Bio-ker S.r.l.Cross Research S.A.; Nerviano Medical Sciences; AAI Deutschland GmbH & Co. KG; Gife...Completed
Clinical Trials on Ergometry H
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ARCIM Institute Academic Research in Complementary...Universität TübingenCompletedHealthy Female SubjectsGermany
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Universitätsklinikum Hamburg-EppendorfDeutsche Multiple Sklerose Gesellschaft HamburgUnknown
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Royal College of Surgeons, IrelandBeaumont Hospital; Post Polio Support Group IrelandCompleted
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Wake Forest University Health SciencesNational Institute on Aging (NIA); National Center for Advancing Translational...Active, not recruitingCritical Illness | Acute Respiratory Distress Syndrome | Critical CareUnited States
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Precordior LtdPaavo Nurmi CentreRecruiting
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Technical University of MadridCompleted
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Riphah International UniversityCompleted
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National University Hospital, SingaporeActive, not recruitingMuscular Atrophy | Critical Care | Exercise Therapy | Calorimetry, IndirectSingapore
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University of LeicesterNational Institute for Health Research, United Kingdom; National Health Service...Completed
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Medical University of ViennaCompletedLiver Diseases | Postoperative Complications | Surgery | Physical StressAustria