Heart Rate Variability as a Clinical Marker in a Population of Anxio-depressive Patients

NCT ID: NCT04192669

Last Updated: 2022-07-19

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

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-11

Study Completion Date

2021-07-13

Brief Summary

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The heart rate (HR) is regulated by the autonomic nervous system (ANS) and results from a balance between the sympathetic nervous system (SNS) that accelerates the heart rate and the parasympathetic nervous system that slows the HR via the vagus nerve.

Low HRV is linked to poor emotional and cognitive regulation. Values for HRV are generally lower in depressed patients.

The aim of this study is to determine how HRV could be a clinical marker that can be used in routine psychiatry practice in patients with anxio-depressive disorders, to determine the severity of symptoms and the degree of response to treatment.

Detailed Description

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Conditions

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Anxio Depressive Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anxio-depressive patients

Patients with a depressive or anxious disorder going to the Psychiatry Department of the CHU Brugmann Hospital.

Heart rate monitoring

Intervention Type DEVICE

The heart rate will be recorded and calculated by a heart rate monitor (Polar H10, Finland) located on the chest. The recording is done over a period of 5 minutes, the patient being in a sitting position, without any particular stimulus, in a quiet room. The recording is transferred via the HRV Logger application. Any ectopic beats and artifacts are automatically identified and replaced by values interpolated by the investigator, if necessary. The Kubios HRV Premium Software is used for all calculations.

Interventions

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Heart rate monitoring

The heart rate will be recorded and calculated by a heart rate monitor (Polar H10, Finland) located on the chest. The recording is done over a period of 5 minutes, the patient being in a sitting position, without any particular stimulus, in a quiet room. The recording is transferred via the HRV Logger application. Any ectopic beats and artifacts are automatically identified and replaced by values interpolated by the investigator, if necessary. The Kubios HRV Premium Software is used for all calculations.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Patients of the CHU Brugmann Hospital with an anxious or depressive disorder

Exclusion Criteria

\- None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tatiana Besse-Hammer

OTHER

Sponsor Role lead

Responsible Party

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Tatiana Besse-Hammer

Head of clinical research unit

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pierre Cole, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

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CHU Brugmann

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CHUB-PSY-BRUHRV

Identifier Type: -

Identifier Source: org_study_id

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