ClinicalTrials.gg
Status unknownNCT04981626INT-ANUpdated Jul 26, 2022

Interoception in Anorexia Nervosa

An observational study in Anorexia, Anorexia Nervosa and Electrocardiogram, sponsored by Fondation Santé des Étudiants de France. Status unknown at 1 site in France. Open to female participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Fondation Santé des Étudiants de France · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
16 Years to 25 Years
Sex
Female
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Study summary

Anorexia nervosa is a serious psychiatric illness whose causes remain poorly understood, and which remains difficult to treat to this day. Many clinical manifestations of this disease can have their origin in abnormalities in the perception of signals coming from inside the body, but this remains to be demonstrated. In recent years, research in healthy subjects has shown how the brain constantly perceives the viscera (heart, lungs, stomach). The examiners will use these new, objective and validated methods to explore how the brain processes information from the viscera (interoception) in anorexic patients. In practice, they will quantify the coupling between the cardiac cycle and involuntary eye movements, as well as between the respiratory cycle and voluntary actions such as pressing a button. Finally, by simultaneously recording the electrical activity of the brain, and that of the stomach, the examiners will measure the coupling between the brain and the stomach. All these measurements, which will be compared between a population of patients and healthy subjects, will make it possible to determine whether anorexic patients have an alteration in the perception of their internal body signals and whether this damage affects several organs.

02

Conditions studied

  • Anorexia
  • Anorexia Nervosa
  • Electrocardiogram
  • EEG
03

In context

Anorexia

163 studies on the registry are indexed under Anorexia; 25 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 29 observational studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

Fondation Santé des Étudiants de France is the lead sponsor of 9 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 25 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

patients with anorexia nervosa (group AN) and healthy control subjects (group C)

Eligibility criteria

Inclusion Criteria - AN groups:

  • Females
  • 6 to 25 years old
  • Diagnostic of AN according to criteria
  • No past or current psychotic disorders
  • No current substance abuse or dependence (excluding tobacco).
  • No current psychiatric medication

Inclusion Criteria - control groups:

  • Females
  • Age : matched for the AN group
  • No present or past eating disorders
  • No past or current psychotic disorders
  • No current substance abuse or dependence.
  • No current psychiatric medication

Exclusion Criteria for both groups:

  • age below 16 years and above 25 years,
  • Past or current psychotic disorders,
  • Current substance abuse or dependence (excluding tobacco)
  • Opposition to participation has been expressed.

In addition, for the control group,

  • Subjects with present or past eating disorders or current mental disorders will be excluded.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control

    * Females * Age : matched for the AN group * No present or past eating disorders * No past or current psychotic disorders * No current substance abuse or dependence. * No current psychiatric medication

    Other: Clinical and experimental session

  • AN group

    * Females * 16 years ≤ Age ≤ 25 years * Diagnostic of AN according to DSM-5 criteria * No past or current psychotic disorders * No current substance abuse or dependence (excluding tobacco). * No current psychiatric medication

    Other: Clinical and experimental session

Interventions

  • OtherClinical and experimental session

    Psychologic profile with standardized interview and scales (see below for details: SCID, BDI, STAI, BPQ, EDE Q, Pictorial Body Image Scale (PBIS) and EDI). Measure the stomach-brain synchrony during EEG/EGG resting state, the distribution of voluntary actions across the respiratory phase, and the distribution of saccadic eye movements across the cardiac-cycle.

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What researchers measure

Primary outcomes

  1. measure brain-stomach interactions using phase-amplitude coupling between the gastric phase and the amplitude of the cortical alpha rhythm.

    Examiners will directly measure brain-stomach interactions using phase-amplitude coupling between the gastric phase and the amplitude of the cortical alpha rhythm.

    Time frame: Experimental session - 10 days maximum after inclusion

07

Study locations

1 of 1 sites recruiting
  • ENS
    Paris, Ile De France 75005, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2022 (actual). Primary completion is estimated for Oct 2022, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2021
First posted
Jul 29, 2021
StartActual
Feb 14, 2022
Primary completionEst.
Oct 2022
CompletionEst.
Apr 2023
Last update
Jul 26, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04981626
Lead sponsor
Fondation Santé des Étudiants de France
Collaborators
Laboratoire de Psychologie et NeuroCognition, University Hospital, Geneva
Responsible party
Sponsor
First posted
Jul 29, 2021
Start date
Feb 14, 2022
Primary completion
Oct 2022 (estimated)
Completion
Apr 2023 (estimated)
Last update
Jul 26, 2022

Study contacts

Nathalie Godart, PU-PH
Contact
nathalie.godart@fsef.net
0145894339
Marco Solca, Dr
Contact
marco.solca@hcuge.ch
Marco Solca, Dr
principal investigator · ENS

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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