Anorexia NervosaUdSA_ANNCT06298526
Auditory Sensory Attenuation in Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women affected by anorexia nervosa and healthy-weight women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 30 Jun 2025
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women affected by anorexia nervosa will be recruited at the IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital, Piancavallo, VB, Italia (eating and nutritional disorders ward). women with healthy weight will be recruited in the local community and among the researchers contacts
Who may be able to join
- diagnosis of anorexia nervosa according to the DSM-V classification (experimental group)
- BMI ranged between 19 - 25 kg/m2 (controls)
- handedness: right
Who cannot join
- history of eating disorders (controls)
- major psychiatric conditions (e.g., psychosis, personality disorders)
- developmental disorders (e.g., autism spectrum disorders)
- neurological or brain injuries disorders
- motor impairments
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital
Piancavallo, VCO, 28824
About this study
Official title: The Sensory Attenuation Paradigm in Auditory Modality in Anorexia Nervosa
The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women affected by anorexia nervosa and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):
- is observed in anorexia nervosa ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.
Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\'s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way.
Read the detailed description
The perceived loudness of a self-generated sound is generally weaker than when another person produces the same sound. This effect is known as sensory attenuation, and it is considered a proof of sense of agency (i.e., it relies on the anticipation of the sensory-motor effects of one\'s intentional action). Recently, it was suggested that this effect is enhanced in interactive action contexts in healthy individuals, meaning that sounds are produced as a consequence of cooperation between individuals.
Participants will compare the loudness of target sound with a comparison tone, which could be generated in 4 different conditions:
- participants press a button ii) the experimenter press the button iii) participants press the button upon the experimenter\'s signal (i.e., who touch the participants\' arm) iv) the experimenter presses the button upon the participants\' signal (i.e., who touch the experimenter\'s arm).
However, it is not clear whether the same effect of cooperation can be observed also when individuals experience difficulties in social interactions and relationships.
To this purpose, the study compared the sensory attenuation effect for auditory stimuli in a traditional (i.e., individual) and interactive context, comparing women affected by anorexia nervosa with healthy-weight women.
Indeed, relational difficulties and social withdrawal characterized this clinical condition.
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, sensory attenuation, anhedonia, cognitive empathy, interpersonal difficulties
- Medical subject headings
- Anorexia Nervosa, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women with anorexia nervosa | DSM-V criteria for anorexia nervosa must be satisfied | |
| healthy weight women | BMI range: 19-29 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
point of subjective equality (PSE)
individual PSE in each experimental condition is obtained by fitting observed judgements of loudness, relative to seven possible comparison tones. The PSE represents the tone loudness that participants perceive as loud as the target sound (i.e., the sound intensity which records only 50% of correct judgments "which sounds was louder?")
Measured: day 1
Secondary outcomes (2)
cognitive empathy
Interpersonal Reactivity Index - IRI: 28-item self-report questionnaire on a 5-point Likert scale (from 1 -does not describe me well to 5 - describes me very well). Four components of cognitive empathy are measured: i) perspective taking (IRI-PT); ii) fantasy (IRI-F); iii) empathic concern (IRI-EC); iv) personal distress (IRI-PD); each subscale includes 7 items (total scores range from 1 to 35): the higher the score, the higher the expression of cognitive empathy described in each subscale.
Measured: day 1
interpersonal pleasure
Anticipatory and Consummatory Interpersonal Pleasure Scale - ACIPS: 17-item self-reported questionnaire scored on 6-point Likert scale (from 1 - very false for me to 6-very true for me). ACIPS total score ranges from 1 to 102: higher scores indicate higher anticipatory and consummatory interpersonal pleasure.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Mar 2023
- Primary completion29 Feb 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298526
- Sponsor's protocol ID
- 21C307
- Acronym
- UdSA_AN
- Status last verified
- Sep 2025
- First submitted
- 1 Mar 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upload of anonymized raw experimental data on public repository (i.e., Zotero)
Publications
Colle L, Hilviu D, Boggio M, Toso A, Longo P, Abbate-Daga G, Garbarini F, Fossataro C. Abnormal sense of agency in eating disorders. Sci Rep. 2023 Aug 30;13(1):14176. doi: 10.1038/s41598-023-41345-5.
PubMed 37648816Weiss C, Herwig A, Schutz-Bosbach S. The self in social interactions: sensory attenuation of auditory action effects is stronger in interactions with others. PLoS One. 2011;6(7):e22723. doi: 10.1371/journal.pone.0022723. Epub 2011 Jul 27.
PubMed 21818373
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sensory Attenuation Paradigm in Auditory Modality in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT06298526
- Acronym / sponsor ID
- UdSA_AN / 21C307
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, sensory attenuation, anhedonia, cognitive empathy, interpersonal difficulties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 Mar 2024 (actual)
- 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 goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women affected by anorexia nervosa and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):
- is observed in anorexia nervosa ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.
Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\'s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way.
Detailed description
The perceived loudness of a self-generated sound is generally weaker than when another person produces the same sound. This effect is known as sensory attenuation, and it is considered a proof of sense of agency (i.e., it relies on the anticipation of the sensory-motor effects of one\'s intentional action). Recently, it was suggested that this effect is enhanced in interactive action contexts in healthy individuals, meaning that sounds are produced as a consequence of cooperation between individuals.
Participants will compare the loudness of target sound with a comparison tone, which could be generated in 4 different conditions:
- participants press a button ii) the experimenter press the button iii) participants press the button upon the experimenter\'s signal (i.e., who touch the participants\' arm) iv) the experimenter presses the button upon the participants\' signal (i.e., who touch the experimenter\'s arm).
However, it is not clear whether the same effect of cooperation can be observed also when individuals experience difficulties in social interactions and relationships.
To this purpose, the study compared the sensory attenuation effect for auditory stimuli in a traditional (i.e., individual) and interactive context, comparing women affected by anorexia nervosa with healthy-weight women.
Indeed, relational difficulties and social withdrawal characterized this clinical condition.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with anorexia nervosa | – | –DSM-V criteria for anorexia nervosa must be satisfied |
| healthy weight women | – | –BMI range: 19-29 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women affected by anorexia nervosa will be recruited at the IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital, Piancavallo, VB, Italia (eating and nutritional disorders ward). women with healthy weight will be recruited in the local community and among the researchers contacts
Key inclusion criteria (3 listed)
- diagnosis of anorexia nervosa according to the DSM-V classification (experimental group)
- BMI ranged between 19 - 25 kg/m2 (controls)
- handedness: right
Key exclusion criteria (5 listed)
- history of eating disorders (controls)
- major psychiatric conditions (e.g., psychosis, personality disorders)
- developmental disorders (e.g., autism spectrum disorders)
- neurological or brain injuries disorders
- motor impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
point of subjective equality (PSE)
Time frame: day 1
individual PSE in each experimental condition is obtained by fitting observed judgements of loudness, relative to seven possible comparison tones. The PSE represents the tone loudness that participants perceive as loud as the target sound (i.e., the sound intensity which records only 50% of correct judgments "which sounds was louder?")
2 secondary outcomes
cognitive empathy
Time frame: day 1
interpersonal pleasure
Time frame: day 1
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 8 Sep 2025.
- Background: PubMed 37648816Colle L, Hilviu D, Boggio M, Toso A, Longo P, Abbate-Daga G, Garbarini F, Fossataro C. Abnormal sense of agency in eating disorders. Sci Rep. 2023 Aug 30;13(1):14176. doi: 10.1038/s41598-023-41345-5.
- Background: PubMed 21818373Weiss C, Herwig A, Schutz-Bosbach S. The self in social interactions: sensory attenuation of auditory action effects is stronger in interactions with others. PLoS One. 2011;6(7):e22723. doi: 10.1371/journal.pone.0022723. Epub 2011 Jul 27.
- Individual participant dataSharing planned: Yes. upload of anonymized raw experimental data on public repository (i.e., Zotero)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Istituto Auxologico Italiano at 1 site in Italy.
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 3 inclusion and 5 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 8 Sep 2025. 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 Italy. 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?
point of subjective equality (PSE) (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06298526, which also lists 2 linked publications.
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 8 Sep 2025.