Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 4 for:    APBA2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03792893
Recruitment Status : Completed
First Posted : January 4, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Universität Tübingen
Information provided by (Responsible Party):
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Female Subjects Other: Ergometry H Other: Ergometry L Not Applicable

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 (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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Comparison of Pulse Wave and Blood Pressure Parameters Before, During and After Exercise Ergometry in Healthy Female Subjects - a Randomized, Controlled, Single-blind Study
Actual Study Start Date : January 29, 2019
Actual Primary Completion Date : May 17, 2019
Actual Study Completion Date : May 17, 2019

Arm Intervention/treatment
Experimental: 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
Other: 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.

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.


Experimental: 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
Other: 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.

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.





Primary Outcome Measures :
  1. Difference of the 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


Secondary Outcome Measures :
  1. Diastolic Blood Pressure (SOMNOtouchTM RESP) [ 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

  2. Mean Arterial Blood Pressure (SOMNOtouchTM RESP) [ 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

  3. Pulse Pressure (SOMNOtouchTM RESP) [ 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

  4. Heartrate (SOMNOtouchTM RESP) [ 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

  5. Oxygen saturation (SpO2, SOMNOtouchTM RESP) [ 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

  6. Pulse-Transit-Time (PTT, SOMNOtouchTM RESP) [ 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

  7. Systolic Blood Pressure measured with the device BOSO-TM-2430 [ 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

  8. Diastolic Blood Pressure measured with the device BOSO-TM-2430 [ 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

  9. Mean Arterial Blood Pressure measured with the device BOSO-TM-2430 [ 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

  10. Pulse Pressure measured with the device BOSO-TM-2430 [ 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

  11. Heartrate measured with the device BOSO-TM-2430 [ 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

  12. Pulse Transit Time (GeTeMed Vitaguard 3100) [ 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

  13. Perfusion Index (GeTeMed Vitaguard 3100) [ 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

  14. Peak to Peak Time (PPT) (GeTeMed Vitaguard 3100) [ 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

  15. SlopeInW1 (GeTeMed Vitaguard 3100) [ 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

  16. SlopeInW2 (GeTeMed Vitaguard 3100) [ 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

  17. SlopeInW3 (GeTeMed Vitaguard 3100) [ 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

  18. SlopeInW4 (GeTeMed Vitaguard 3100) [ 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

  19. StiffnessIndex (GeTeMed Vitaguard 3100) [ 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

  20. ReflectionIndex (GeTeMed Vitaguard 3100) [ 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

  21. TimeTX (GeTeMed Vitaguard 3100) [ 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

  22. TimeTY (GeTeMed Vitaguard 3100) [ 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

  23. QuotTYTX (GeTeMed Vitaguard 3100) [ 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

  24. AreaAX (GeTeMed Vitaguard 3100) [ 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

  25. AreaAY (GeTeMed Vitaguard 3100) [ 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

  26. QuotAYAX (GeTeMed Vitaguard 3100) [ 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

  27. AreaAV (GeTeMed Vitaguard 3100) [ 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

  28. AreaAW (GeTeMed Vitaguard 3100) [ 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

  29. QuotAWAV (GeTeMed Vitaguard 3100) [ 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

  30. QuotTVTW (GeTeMed Vitaguard 3100) [ 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

  31. TimeTV (GeTeMed Vitaguard 3100) [ 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

  32. TimeTW (GeTeMed Vitaguard 3100) [ 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

  33. MinT1 (GeTeMed Vitaguard 3100) [ 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

  34. MinT2 (GeTeMed Vitaguard 3100) [ 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

  35. MaxT1 (GeTeMed Vitaguard 3100) [ 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

  36. MaxT2 (GeTeMed Vitaguard 3100) [ 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

  37. QuotHRRespRate (GeTeMed Vitaguard 3100) [ 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792893


Locations
Layout table for location information
Germany
ARCIM Institute
Filderstadt, Baden Württemberg, Germany, 70794
Sponsors and Collaborators
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Universität Tübingen
Investigators
Layout table for investigator information
Study Director: Jan Vagedes, MD ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany

Layout table for additonal information
Responsible Party: ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT03792893     History of Changes
Other Study ID Numbers: ERG_03
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ARCIM Institute Academic Research in Complementary and Integrative Medicine:
Cardiovascular parameters
Blood Pressure
Pulse Wave
Ergometry
Somnotouch
BOSO-TM-2430