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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05485129

Enrollment

Registered

2022-08-03

Start date

2022-07-01

Completion date

2022-12-01

Last updated

2022-08-04

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

Conditions

Stress

Brief summary

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.

Interventions

DEVICEBIORICS

Wearing BIORICS in their ear and perform mental arrhythmic test, relaxation exercises and Stroop test

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Heart rate variability measured BIOMETRIC in-ear device	1 day	RMSSD

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026