Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa (VARIASTRESS)

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.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Other: Heart rate monitor

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistical correlation between autonomic dysfunction (measured by HRV) and anxiety (measured by questionnaire)	The composite measure consists of the following :- Time and spectral-domain measures of HRV measured by nocturn registration with heart rate monitor and polar RS800CX Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (Number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50 (NN50/total number of all NN), SDANN (Standard deviation of the average of NN intervals in all 5-minute segments of a long recording), SDNNIDX (Mean of the standard deviation in all 5-minute segments of a long recording) Frequency domain - VLF Power (very low frequency; <0.04 Hz), LF Power (low frequency; 0.04~0.15 Hz), HF Power (high frequency; 0.15~0.4 Hz), LF/HF ratio value - State-Trait Anxiety Inventory: version Y (STAI- form Y) - Morning blood cortisol level and serum prealbumin lev	at day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory	Beck Depression inventory : Version 2 in french (BDI-II)	at day 0
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory	Beck Depression inventory : Version 2 in french (BDI-II)	at 6 months
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire	International physical activity questionnaire (IPAQ) - French version	at 6 months
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire	International physical activity questionnaire (IPAQ) - French version	at day 0

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Sylvain ICETA, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): September 12, 2018
• Study Completion (Actual): September 12, 2018

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 27, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: anxiety; Heart rate variability; Autonomic dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 69HCL16_0376; 2016-A01659-42 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No