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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Heart rate monitor
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anorexia Nervosa focused on measuring Heart rate variability, anxiety, Autonomic dysfunction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart rate monitor

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory
Beck Depression inventory : Version 2 in french (BDI-II)
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory
Beck Depression inventory : Version 2 in french (BDI-II)
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire
International physical activity questionnaire (IPAQ) - French version
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire
International physical activity questionnaire (IPAQ) - French version

Full Information

First Posted
December 22, 2016
Last Updated
December 11, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03003429
Brief Title
Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa
Acronym
VARIASTRESS
Official Title
Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
September 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Heart rate variability, anxiety, Autonomic dysfunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart rate monitor
Arm Type
Experimental
Arm Description
The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX
Intervention Type
Other
Intervention Name(s)
Heart rate monitor
Intervention Description
The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX
Primary Outcome Measure Information:
Title
Statistical correlation between autonomic dysfunction (measured by HRV) and anxiety (measured by questionnaire)
Description
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
Time Frame
at day 0
Secondary Outcome Measure Information:
Title
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory
Description
Beck Depression inventory : Version 2 in french (BDI-II)
Time Frame
at day 0
Title
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory
Description
Beck Depression inventory : Version 2 in french (BDI-II)
Time Frame
at 6 months
Title
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire
Description
International physical activity questionnaire (IPAQ) - French version
Time Frame
at 6 months
Title
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire
Description
International physical activity questionnaire (IPAQ) - French version
Time Frame
at day 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvain ICETA, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

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Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

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