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

NCT ID: NCT05485129

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-12-01

Brief Summary

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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

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Conditions

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Stress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

BIORICS

Intervention Type DEVICE

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

Interventions

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BIORICS

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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prof. dr. Paul Dendale

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jessa Hospital

Hasselt, Limburg, Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Martijn Scherrenberg, MD

Role: primary

+32 11 33 70 30

Other Identifiers

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SQUID

Identifier Type: -

Identifier Source: org_study_id

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