MedDataX Logo

Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

NCT ID: NCT03003429

Last Updated: 2019-12-12

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-09-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The heart rate variability (HRV) is a measure of the autonomic nervous system (ANS). In the model of anorexia nervosa, ANS is disturbed with mostly a predominance of activation of the parasympathetic nervous system and a decrease of the sympathetic system. Various explanations of this these dysfunctions are proposed in literature, mainly malnutrition, physical hyperactivity, anxiety, that are known characteristics of anorexia nervosa.

The primary aim of this study is to evaluate correlation between ANS dysfunction and anxiety in anorexia nervosa.

Other objectives of this study are firstly to evaluate correlation between ANS dysfunction and others parameters (weight, body mass index, depression, physical activity, purgative ou restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if HRV is a predictive parameter of the evolution of anorexia nervosa.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anorexia Nervosa

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Heart rate variability anxiety Autonomic dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Heart rate monitor

The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX

Group Type EXPERIMENTAL

Heart rate monitor

Intervention Type OTHER

The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Heart rate monitor

The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women
* Aged from 18 to 65 years
* Criteria of anorexia nervosa (DSM V)
* Body mass index (BMI) \< 18 kg/m2
* Written consent to participate in the study
* Patient affiliated to a social security system

Exclusion Criteria

* Pacemaker or other implantable electronic device
* Current comorbidity psychiatric disorder according to Axis I of DSM IV : severe depression (BDI \> 8/13), substance use disorder .
* Psychotropic drugs or ongoing steroid therapy ;
* Pregnancy or breast-feeding ;
* History or known cardiovascular disorder, including hypertension ( \> 140/90 mmHg ) , heart failure, arrhythmia and conduction disorder .
* Major protected by a legal protection
* Minors
* Patient involved in another research with an exclusion period ongoing at the run-in
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sylvain ICETA, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospices Civils de Lyon

Bron, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-A01659-42

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL16_0376

Identifier Type: -

Identifier Source: org_study_id