ARCIM Institute
Filderstadt, Baden-Wurttemberg, 70794, Germany
NCT Number: NCT03792893
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.
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Filderstadt, Baden-Wurttemberg, 70794, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Primary outcome is the difference of the systolic blood pressure values between the devices BOSO-TM-2430 versus SOMNOtouchTM RESP during the three phases
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Diastolic Blood Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
Time frame: 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 (mm Hg) measured with the SOMNOtouchTM RESP device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Pulse Pressure (mm Hg) measured with the SOMNOtouchTM RESP device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Heartrate (beats per minute, bpm) measured with the SOMNOtouchTM RESP device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Oxygen saturation (% SpO2) measured with the SOMNOtouchTM RESP device
Time frame: 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, ms) measured with the SOMNOtouchTM RESP device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Systolic Blood Pressure (mmHg) measured with the BOSO-TM-2430 device
Time frame: 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
Time frame: 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
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Pulse Pressure (mmHg) measured with the BOSO-TM-2430 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Heartrate (beats per minute, bpm) measured with the BOSO-TM-2430 device
Time frame: 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, ms) measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Perfusion Index (PI) measured with the GeTeMed Vitaguard 3100 device
Time frame: 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, ms) measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
SlopeInW1 measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
SlopeInW2 measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
SlopeInW3 measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
SlopeInW4 measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
StiffnessIndex measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
ReflectionIndex measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
TimeTX (ms) measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
TimeTY (ms) measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
QuotTYTX measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
AreaAX measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
AreaAY measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
QuotAYAX measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
AreaAV measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
AreaAW measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
QuotAWAV measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
QuotTVTW measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
TimeTV (ms) measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
TimeTW (ms) measured with the GeTeMed Vitaguard 3100 device
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the first peak
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the first peak
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the maximum of the second peak
Time frame: Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100 device
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Other
Comparison of Pulse Wave and Blood Pressure Parameters Before, During and After Exercise Ergometry in Healthy Female Subjects - a Randomized, Controlled, Single-blind Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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