Auditory Sensory Attenuation in Obesity (Ud_SA_OB)

March 8, 2024 updated by: Istituto Auxologico Italiano

The Sensory Attenuation Paradigm in Auditory Modality in Obesity

The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women with obesity 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):

i) is observed in obesity 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.

Study Overview

Status

Active, not recruiting

Conditions

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:

i) 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 with obesity and healthy-weight women.

Indeed, relational difficulties and social withdrawal characterized this clinical condition.

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • VCO
      • Piancavallo, VCO, Italy, 28824
        • IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

women with obesity will be recruited at the IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital, Piancavallo, VB, Italia during their rehabilitative treatment.

Healthy weight participants will be recruited in the local community and among researchers' contacts.

Description

Inclusion Criteria:

  • BMI > 30 kg/m2 (controls)
  • handedness: right

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Obesity
BMI > 30 kg/m2
Healthy weight
BMI range: 19 - 29 kg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?")
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive empathy
Time Frame: day 1
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.
day 1
interpersonal pleasure
Time Frame: day 1
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.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Collaborators

University of Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21C308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

anonymized experimental raw data

IPD Sharing Access Criteria

upon reasonable request to the Authors through the repository platform. Log-in on the platform is required.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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