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Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03003429
Acronym
VARIASTRESS
Enrollment
13
Registered
2016-12-28
Start date
2017-03-01
Completion date
2018-09-12
Last updated
2019-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

Keywords

Heart rate variability, anxiety, Autonomic dysfunction

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.

Interventions

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Statistical correlation between autonomic dysfunction (measured by HRV) and anxiety (measured by questionnaire)at day 0The 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

MeasureTime frameDescription
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventoryat day 0Beck Depression inventory : Version 2 in french (BDI-II)
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaireat 6 monthsInternational physical activity questionnaire (IPAQ) - French version

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026