- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05768633
Counterfactual Thinking and Decision-making in OSA Syndrome (CT_OSAS)
August 20, 2025 updated by: Istituto Auxologico Italiano
Counterfactual Thinking About Clinical Decision and Decision-making in the Context of Obstructive Sleep Apnea Syndrome.
The aim of this research is to verify the ability of counterfactual thinking about medical decisions in individuals with obstructive sleep apnea syndrome when compared with healthy individuals
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
70
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
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VCO
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Piancavallo, VCO, Italy, 28824
- IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
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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
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Participants with obstructive sleep apnea syndrome consecutively recruited at the beginning of their rehabilitative treatment at the IRCCS Istituto Auxologico Italiano.
Description
Inclusion Criteria:
- Diagnosis of obstructive sleep apnea syndrome, according to the clinical assessment.
Exclusion Criteria:
- Concurrent neurological, neurodevelopmental (e.g., autism), motor, and/or psychiatric disorders
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 |
Intervention / Treatment |
|---|---|
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Controls
Age-matched healthy individuals recruited outside the hospital through personal contacts of the researchers and word-of-mouth.
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All participants will be asked to complete the Counterfactual Inference Test - CIT (McNamara et al., 2003), a neuropsychological test that measures the ability to produce counterfactual-derived inferences.
Moreover, the decision-making ability will be specifically tested through ad-hoc questionnaire (i.e., the Decision-Making Questionnaire).
Finally, all participants will be screened with an extensive neuropsychological assessment, particularly on executive functioning.
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Cases
Individuals diagnosed with obstructive sleep apnea (OSA) syndrome recruited at the beginning of rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).
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All participants will be asked to complete the Counterfactual Inference Test - CIT (McNamara et al., 2003), a neuropsychological test that measures the ability to produce counterfactual-derived inferences.
Moreover, the decision-making ability will be specifically tested through ad-hoc questionnaire (i.e., the Decision-Making Questionnaire).
Finally, all participants will be screened with an extensive neuropsychological assessment, particularly on executive functioning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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CIT score
Time Frame: Baseline
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Score at the Counterfactual inference test (CIT).
The questionnaire is a four question forced choice test based on past research regarding factors that enhance counterfactual thinking.
For each of the four questions, events experienced by two individuals are presented, and three response options are given.
Only one option is the valid: the score is 1.
For the not valid options, the score will be 0. Overall, the score range for the questionnaire is from 0 (worse performance) to 4 (best performance).
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Decision-making index
Time Frame: Baseline
|
Score at the Decision-Making Questionnaire.
The self-report questionnaire assesses the decision making ability according to 7 questions, with a 5-item Likert's scale.
The overall score (i.e., the sum of the scores at all questions) can range from 7 (worse decision making strategy) to 35 (best decision making strategy).
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sofia Tagini, PhD, IRCCS Istituto Auxologico Italiano
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 2, 2022
Primary Completion (Actual)
March 1, 2024
Study Completion (Actual)
March 1, 2024
Study Registration Dates
First Submitted
February 22, 2023
First Submitted That Met QC Criteria
March 3, 2023
First Posted (Actual)
March 14, 2023
Study Record Updates
Last Update Posted (Estimated)
August 27, 2025
Last Update Submitted That Met QC Criteria
August 20, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23C211
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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