Feasability Assessment of wearable sensors for continuous ambulatory vital signs monitoring

Feasability Assessment of wearable sensors for continuous ambulatory vital signs monitoring - Vital signs monitoring with wearable sensors

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48983

Enrollment

Registered

2019-03-06

Start date

2019-04-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dit betreft een validatie studie van continue metingen van vitale functies, welke niet gerelateerd is aan een enkele aandoening of orgaansysteem Not applicable

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Study 1 10 volunteers of both sexes (*18 years of age) are eligible for enrolment, with the following criteria: * 5 volunteers need to be at age 65 or above * 3 volunteers need to have a BMI >30 kg/m2, Study 2 10 volunteers ( *18 years of age) are eligible for enrolment, with the following criteria: * At least one hospitalization requiring monitoring in the past two years (*former patients*) * Currently healthy or in a stable phase of chronic illness * 3 volunteers need to have a BMI >30 kg/m2 * 3 volunteers need to live alone (without informal carer)

Exclusion criteria

Exclusion criteria: * Known allergy/skin irritation to the adhesives used in the sensor patches. * Implanted active medical devices, such as a cardioverter defibrillator or a pacemaker * Current pregnancy * Inability to give informed consent

Design outcomes

Primary

Measure	Time frame
Study 1 Primary outcome is the accuracy of the vital sign parameters that each prototype solution measures as compared with the reference standard. Study 2 The primary outcome measure of study 2 is the usability of each of the prototype solutions, as measured with the system usability scale (SUS).	—

Secondary

Measure	Time frame
The secondary outcome measure of study 2 is the technical feasibility of ambulatory monitoring at home, which will be evaluated with the following metrics: * Success rate of data transmission to external server or gateway device, calculated as percentage: [(actual data points captured / intended data points)] o Duration of interrupted monitoring episodes (e.g., data gaps of 15 minutes, 1 hour, 8 hours or more) o Frequency of interrupted monitoring episodes (e.g., data gaps) o The level of accessibility of the measured data	—

Measure

Time frame

The secondary outcome measure of study 2 is the technical feasibility of ambulatory monitoring at home, which will be evaluated with the following metrics: * Success rate of data transmission to external server or gateway device, calculated as percentage: [(actual data points captured / intended data points)] o Duration of interrupted monitoring episodes (e.g., data gaps of 15 minutes, 1 hour, 8 hours or more) o Frequency of interrupted monitoring episodes (e.g., data gaps) o The level of accessibility of the measured data

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Countries

Netherlands

Outcome results