NCT05768633

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

February 22, 2023

Last Update Submit

August 20, 2025

Conditions

Keywords

counterfactual thinkingdecision-makingneuropsychological assessmentclinical setting

Outcome Measures

Primary Outcomes (1)

  • CIT score

    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).

    Baseline

Secondary Outcomes (1)

  • Decision-making index

    Baseline

Study Arms (2)

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).

Behavioral: Counterfactual Inference Test

Controls

Age-matched healthy individuals recruited outside the hospital through personal contacts of the researchers and word-of-mouth.

Behavioral: Counterfactual Inference Test

Interventions

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.

CasesControls

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- Diagnosis of obstructive sleep apnea syndrome, according to the clinical assessment.

You may not qualify if:

  • \- Concurrent neurological, neurodevelopmental (e.g., autism), motor, and/or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, 28824, Italy

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Sofia Tagini, PhD

    IRCCS Istituto Auxologico Italiano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 14, 2023

Study Start

March 2, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

August 27, 2025

Record last verified: 2025-08

Locations