Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Pulse Wave and Blood Pressure Parameters Before, During and After Exercise Ergometry in Healthy Female Subjects - a Randomized, Controlled, Single-blind Study

Conditions
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Healthy Female Subjects

Intervention / Treatment
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* Other: Ergometry H
* Other: Ergometry L


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Higher Blood Pressure<br>BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure. Intervention: Ergometry H | Other: Ergometry H<br>* 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.<br>|
| Experimental: Lower Blood Pressure<br>BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure. Intervention: Ergometry L | Other: Ergometry L<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of the systolic blood pressure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure (SOMNOtouchTM RESP) | Diastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device | 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 (SOMNOtouchTM RESP) | Mean Arterial Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| Pulse Pressure (SOMNOtouchTM RESP) | Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| Heartrate (SOMNOtouchTM RESP) | Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| Oxygen saturation (SpO2, SOMNOtouchTM RESP) | Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| Pulse-Transit-Time (PTT, SOMNOtouchTM RESP) | Pulse-Transit-Time (PTT, ms) measured with the SOMNOtouchTM RESP device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| Systolic Blood Pressure measured with the device BOSO-TM-2430 | Systolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| Diastolic Blood Pressure measured with the device BOSO-TM-2430 | Diastolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device | 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 measured with the device BOSO-TM-2430 | Mean Arterial Blood Pressure (mmHg) measured with the BOSO-TM-2430 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| Pulse Pressure measured with the device BOSO-TM-2430 | Pulse Pressure (mmHg) measured with the BOSO-TM-2430 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| Heartrate measured with the device BOSO-TM-2430 | Heartrate (beats per minute, bpm) measured with the BOSO-TM-2430 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| Pulse Transit Time (GeTeMed Vitaguard 3100) | Pulse Transit Time (PTT, ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| Perfusion Index (GeTeMed Vitaguard 3100) | Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100) | Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| SlopeInW1 (GeTeMed Vitaguard 3100) | SlopeInW1 measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| SlopeInW2 (GeTeMed Vitaguard 3100) | SlopeInW2 measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| SlopeInW3 (GeTeMed Vitaguard 3100) | SlopeInW3 measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| SlopeInW4 (GeTeMed Vitaguard 3100) | SlopeInW4 measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| StiffnessIndex (GeTeMed Vitaguard 3100) | StiffnessIndex measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| ReflectionIndex (GeTeMed Vitaguard 3100) | ReflectionIndex measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| TimeTX (GeTeMed Vitaguard 3100) | TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| TimeTY (GeTeMed Vitaguard 3100) | TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| QuotTYTX (GeTeMed Vitaguard 3100) | QuotTYTX measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| AreaAX (GeTeMed Vitaguard 3100) | AreaAX measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| AreaAY (GeTeMed Vitaguard 3100) | AreaAY measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| QuotAYAX (GeTeMed Vitaguard 3100) | QuotAYAX measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| AreaAV (GeTeMed Vitaguard 3100) | AreaAV measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| AreaAW (GeTeMed Vitaguard 3100) | AreaAW measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| QuotAWAV (GeTeMed Vitaguard 3100) | QuotAWAV measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| QuotTVTW (GeTeMed Vitaguard 3100) | QuotTVTW measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| TimeTV (GeTeMed Vitaguard 3100) | TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| TimeTW (GeTeMed Vitaguard 3100) | TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| MinT1 (GeTeMed Vitaguard 3100) | 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 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| MinT2 (GeTeMed Vitaguard 3100) | 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 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| MaxT1 (GeTeMed Vitaguard 3100) | 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 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| MaxT2 (GeTeMed Vitaguard 3100) | 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 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 
| QuotHRRespRate (GeTeMed Vitaguard 3100) | Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device | Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular parameters, Blood Pressure, Pulse Wave, Ergometry, Somnotouch, BOSO-TM-2430