Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— VARIASTRESS  

Official title:

Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003429
• Other study ID #: 69HCL16_0376
• Secondary ID: 2016-A01659-42
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: September 12, 2018

Study information

• Verified date: December 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 12, 2018
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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