Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 7:13 AM
Study NCT ID:
NCT05768633
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2023-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Counterfactual Thinking and Decision-making in OSA Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CIT score', 'timeFrame': 'Baseline', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Decision-making index', 'timeFrame': 'Baseline', 'description': "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)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['counterfactual thinking', 'decision-making', 'neuropsychological assessment', 'clinical setting'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with obstructive sleep apnea syndrome consecutively recruited at the beginning of their rehabilitative treatment at the IRCCS Istituto Auxologico Italiano.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Diagnosis of obstructive sleep apnea syndrome, according to the clinical assessment.\n\nExclusion Criteria:\n\n\\- Concurrent neurological, neurodevelopmental (e.g., autism), motor, and/or psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT05768633', 'acronym': 'CT_OSAS', 'briefTitle': 'Counterfactual Thinking and Decision-making in OSA Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Counterfactual Thinking About Clinical Decision and Decision-making in the Context of Obstructive Sleep Apnea Syndrome.', 'orgStudyIdInfo': {'id': '23C211'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': '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).', 'interventionNames': ['Behavioral: Counterfactual Inference Test']}, {'label': 'Controls', 'description': 'Age-matched healthy individuals recruited outside the hospital through personal contacts of the researchers and word-of-mouth.', 'interventionNames': ['Behavioral: Counterfactual Inference Test']}], 'interventions': [{'name': 'Counterfactual Inference Test', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Cases', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28824', 'city': 'Piancavallo', 'state': 'VCO', 'country': 'Italy', 'facility': 'IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe', 'geoPoint': {'lat': 46.00932, 'lon': 8.62916}}], 'overallOfficials': [{'name': 'Sofia Tagini, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituto Auxologico Italiano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}