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

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 male subjects.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Baden Württemberg
      • Filderstadt, Baden Württemberg, Germany, 70794
        • Arcim Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Jan Vagedes, MD, ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2019

Primary Completion (Actual)

May 22, 2019

Study Completion (Actual)

May 22, 2019

Study Registration Dates

First Submitted

December 27, 2018

First Submitted That Met QC Criteria

December 28, 2018

First Posted (Actual)

January 2, 2019

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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