Physiological basis and user acceptance of radar-based epilepsy diagnostics

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 57

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

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;

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study part 1:<br>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.<br><br>Study part 2:<br>Stakeholder acceptance factors and attitude can be presented.

Secondary Outcome Measures

Name	Time	Method
The planned number of participants has been achieved:<br><br>- Study part 1: <br>n=30<br><br>- Study part 2:<br>Participant observation (n = 10); focus groups (n = 6 to 12 per focus group); semistructured interviews (n = 12 to 15; until data saturation).