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NCT05485129 Clinical Trial

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

Stress Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05485129
Other study ID # SQUID
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 1, 2022

Study information
Verified date August 2022
Source Hasselt University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium Jessa Hospital Hasselt Limburg

Sponsors (1)
Lead Sponsor Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Heart rate variability measured BIOMETRIC in-ear device RMSSD 1 day
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