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

August 2, 2022 updated by: prof. dr. Paul Dendale, Hasselt University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Recruiting
        • Jessa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability measured BIOMETRIC in-ear device
Time Frame: 1 day
RMSSD
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2022

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (ACTUAL)

August 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • SQUID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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