Use of HRV Measuring Hearing-aid Device to Detect Acute S... | NCT05485129

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

NCT05485129

Sponsor

Hasselt University

Status

Unknown status

Last Update Posted

Aug 4, 2022Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Stress

Interventions

BIORICS

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Aug 1, 2022

First Submission Date that Met QC Criteria

Aug 1, 2022

First Posted Date

Aug 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2022

Last Update Posted Date

Aug 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Device: BIORICS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIORICS	Device	Wearing BIORICS in their ear and perform mental arrhythmic test, relaxation exercises and Stroop test	Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jessa Hospital	Recruiting	Hasselt	Limburg	3500	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided