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Completed

NCT Number: NCT03003429

Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

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.

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Key information

Conditions

Anorexia Nervosa Anxiety Disorders Autonomic Nervous System Diseases Feeding and Eating Disorders Mental Disorders Nervous System Diseases Primary Dysautonomias

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart rate monitor

Other

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

Primary outcomes

  1. Statistical correlation between autonomic dysfunction (measured by HRV) and anxiety (measured by questionnaire)

    Time frame: at day 0

    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

Secondary outcomes

  1. Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory

    Time frame: at day 0

    Beck Depression inventory : Version 2 in french (BDI-II)

  2. Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory

    Time frame: at 6 months

    Beck Depression inventory : Version 2 in french (BDI-II)

  3. Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire

    Time frame: at 6 months

    International physical activity questionnaire (IPAQ) - French version

  4. Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire

    Time frame: at day 0

    International physical activity questionnaire (IPAQ) - French version

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: VARIASTRESS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2016
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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