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Trial record 16 of 50 for:    Recruiting, Not yet recruiting, Available Studies | "Anorexia Nervosa"

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

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ClinicalTrials.gov Identifier: NCT03003429
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Anorexia Nervosa Other: Heart rate monitor Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003429


Contacts
Contact: Sylvain ICETA, MD 4 27 85 60 11 ext +33 sylvain.iceta@chu-lyon.fr
Contact: Bérénice SEGRESTIN, MD 427 85 60 11 ext +33 berenice.segrestin@chu-lyon.fr

Locations
France
Hospices Civils de Lyon Recruiting
Bron, France, 69500
Contact: Sylvain ICETA         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sylvain ICETA, MD Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03003429     History of Changes
Other Study ID Numbers: 69HCL16_0376
2016-A01659-42 ( Other Identifier: ID-RCB )
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Heart rate variability
anxiety
Autonomic dysfunction

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders