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

Not Applicable

• Conditions: Stress
• Interventions: Device: BIORICS

• Registration Number: NCT05485129
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-01
• Last Update Submitted: 2022-08-02
• Study First Posted: 2022-08-03
• Last Update Posted: 2022-08-04
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	BIORICS	-

Primary Outcome Measures

Name	Time	Method
Heart rate variability measured BIOMETRIC in-ear device	1 day	RMSSD

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium