- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03792893
Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Women
Comparison of Pulse Wave and Blood Pressure Parameters Before, During and After Exercise Ergometry in Healthy Female Subjects - a Randomized, Controlled, Single-blind Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Baden Württemberg
-
Filderstadt, Baden Württemberg, Tyskland, 70794
- Arcim Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
|
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. |
Eksperimentel: 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
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Difference of the systolic blood pressure
Tidsramme: 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
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Diastolic Blood Pressure (SOMNOtouchTM RESP)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
Heartrate (SOMNOtouchTM RESP)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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
Tidsramme: 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
|
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
Tidsramme: 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
|
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
Tidsramme: 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
|
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
Tidsramme: 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
|
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
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
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)
Tidsramme: 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
|
Physiological parameters are measured continuously (SOMNOtouchTM RESP) and every 2 minutes (BOSO-TM-2430) for a total duration of 72 minutes
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studieleder: Jan Vagedes, MD, ARCIM Institute, Im Haberschlai 7, 70794 Filderstadt, Germany
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
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