Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

NCT03003429 | Completed

• 2 other identifiers: 69HCL16_03762016-A01659-42
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anorexia Nervosa

Keywords

Heart rate variability; anxiety; Autonomic dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  at day 0

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

  at 6 months

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

  at 6 months

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

  at day 0

Study Arms (1)

Heart rate monitor

EXPERIMENTAL

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

Interventions

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

Heart rate monitor

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Anorexia Nervosa; Anxiety Disorders; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Sylvain ICETA, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: December 28, 2016
• Study Start: March 1, 2017
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

FR (1)