Use of HRV Measuring Hearing-aid Device to Detect Acute Stress

Hasselt University

Status: Enrolling

Conditions: Stress

Treatments: Device: BIORICS

Study type: Interventional

Funder types: Other

Identifiers

NCT05485129

SQUID

Details and patient eligibility

About

Validation of in-ear device to measure acute mental stress in comparison with a Polar H10 chest band. Stress is measured on the basis of heart rate variability.

Enrollment: 30 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Dutch speaking and understanding
• Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally recognized representative) has been informed of all pertinent aspects of the study
• Age ≥ 50 years
• No contra-indications for the use of the receiver in-the-ear device (BiometRIC SR 26UAA01GF), and smartwatch and chest strap heartrate monitor

Exclusion criteria

• • Smokers

  • Obese patients (BMI >30 kg/m2)
  • Presence of a pacemaker
  • Supraventricular tachycardias: atrial fibrillation, atrial flutter, frequent supraventricular extrasystole or frequent ventricular extrasystole
  • Otologic contraindications determined by licensed otolaryngologist

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Intervention

Experimental group

Treatment:

Device: BIORICS