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

Sponsor

Hasselt University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05485129

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress	Device: BIORICS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Device: BIORICS Wearing BIORICS in their ear and perform mental arrhythmic test, relaxation exercises and Stroop test

Arm

Intervention/Treatment

Experimental: Intervention

Device: BIORICS

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

Outcome Measures

Primary Outcome Measures

Heart rate variability measured BIOMETRIC in-ear device [1 day]
RMSSD

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jessa Hospital	Hasselt	Limburg	Belgium	3500

Sponsors and Collaborators

Hasselt University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

prof. dr. Paul Dendale, Professor, Hasselt University

ClinicalTrials.gov Identifier:

NCT05485129

Other Study ID Numbers:

SQUID

First Posted:

Aug 3, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 4, 2022