healthy adult volunteers (see inclusion criteria)
Conditions
Interventions
Group 1: Study part 1: planned start of this part: May 2022
indicated measurements: contactless measurements with bioradar (non-contact measurement of body surface movements induced by respiration and heartbeat) and gold standard validation with task force mon
single examination of the healthy volunteers with an approximate examination duration of 2 hours
Study part 2: planned start of this part: December 2021
indicated assessment: accompanying observation (neuropediatricians, nursing staff, medical assistants
single observation per study participant of approximately 4 hours), focus groups (neuropediatricians, nursing staff, medical assistants
2 focus groups (outpatient and inpatient setting) of 60 minutes each), and semistructured interviews (parents of children with epilepsy
single interview
duration 60 minutes)
>> planned end of the whole study: December 2022
Sponsors
Universitätsklinikum Erlangen, Palliativmedizinsche Abteilung, Friedrich-Alexander-Universität Erlangen-Nürnberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Study part 1: - no known coronary disease - body height: max. 175 cm (limitation due to measurement setup) - written consent of the participant after detailed information - in case of arterial hypertension, this must be controlled by medication within the normal limits without taking beta- or alpha-receptor blockers Study part 2: For participant observation: - staff members of the neuropediatric ward and outpatient clinic of the University Hospital Erlangen - directly involved in the care of pediatric epilepsy patients - qualifications: neuropediatricians, nursing staff, medical assistants; For the focus groups: - staff of the neuropediatric ward and outpatient clinic of University Hospital Erlangen. - staff of the neurological practice in Fürth - staff of other neuropediatric specialist practices and clinics - employees with professional and thematic expertise in the field of neuropediatrics / epilepsy diagnostics - directly involved in the care of pediatric epilepsy patients; For the semi-structured interviews: - father, mother, or the legal guardian(s) of a child with epilepsy - child's age: newborn to 17 years of age - outpatient or inpatient treatment/care of the epilepsy patient in the neuropediatric department of the University Hospital Erlangen at the time of data collection;
Exclusion criteria
Exclusion criteria: Study part 1: - age: less than 18 years - known coronary disease, known cardiac arrhythmias - untreated hypertension - use of beta-blockers or centrally depressant substances (benzodiazepines, barbiturates, antiepileptic drugs) - known epilepsy or history of occasional seizures - positive history of syncope - neurodegenerative disease - cancer - renal or hepatic insufficiency; Study part 2: - age: less than 18 years - no informed consent for study participation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study part 1: Distance changes between the bioradar and the body surface can be reliably recorded so that heartbeat, heart rate, and heart rate variability can be derived from the radar data. Study part 2: Stakeholder acceptance factors and attitude can be presented. | — |
Secondary
| Measure | Time frame |
|---|---|
| The planned number of participants has been achieved: - Study part 1: n=30 - Study part 2: Participant observation (n = 10); focus groups (n = 6 to 12 per focus group); semistructured interviews (n = 12 to 15; until data saturation). | — |
Countries
Germany
Contacts
Public ContactIsabell Klinger
Universitätsklinikum Erlangen, Palliativmedizinische Abteilung
Outcome results
None listed