Anorexia NervosaVARIASTRESSNCT03003429
Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa
A study testing Heart rate monitor in people with Anorexia Nervosa, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Heart rate monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 12 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Heart rate monitor
- Keywords
- Heart rate variability, anxiety, Autonomic dysfunction
- Medical subject headings
- Anorexia Nervosa, Anxiety Disorders, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate monitorOther
The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Heart rate monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 0
Secondary outcomes (4)
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory
Beck Depression inventory : Version 2 in french (BDI-II)
Measured: at day 0
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory
Beck Depression inventory : Version 2 in french (BDI-II)
Measured: at 6 months
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire
International physical activity questionnaire (IPAQ) - French version
Measured: at 6 months
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire
International physical activity questionnaire (IPAQ) - French version
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start1 Mar 2017
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain ICETA, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003429
- Sponsor's protocol ID
- 69HCL16_0376
- Other IDs
- 2016-A01659-42
- Acronym
- VARIASTRESS
- Status last verified
- Dec 2019
- First submitted
- 22 Dec 2016
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03003429
- Acronym / sponsor ID
- VARIASTRESS / 69HCL16_0376
- Conditions
- Anorexia Nervosa
- Keywords
- Heart rate variability, anxiety, Autonomic dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart rate monitor | Experimental | Other: Heart rate monitorThe intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate monitorThe 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 |
Primary outcome
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
4 secondary outcomes
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory
Time frame: at day 0
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of Beck Depression inventory
Time frame: at 6 months
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire
Time frame: at 6 months
Statistical correlation between autonomic dysfunction (measured by HRV) and measures of International physical activity questionnaire
Time frame: at day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain ICETA, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate monitor in people with Anorexia Nervosa, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical correlation between autonomic dysfunction (measured by HRV) and anxiety (measured by questionnaire) (time frame: at day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.