NCT05485129

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 1, 2022

Last Update Submit

August 2, 2022

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability measured BIOMETRIC in-ear device

    RMSSD

    1 day

Study Arms (1)

Intervention

EXPERIMENTAL
Device: BIORICS

Interventions

BIORICSDEVICE

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

Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 3, 2022

Study Start

July 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)