Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT06312956
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], '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': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample for biomarkers analysis (i.e., orexin, histamine, light chain neurofilaments, Ab42, Ab40)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall cognitive functioning', 'timeFrame': 'baseline and after 3 weeks', 'description': 'Montreal Cognitive Assessment MoCA (score range: 0-30; higher scores indicate higher cognitive functioning)'}, {'measure': 'Selective attention', 'timeFrame': 'baseline and after 3 weeks', 'description': 'Multiple Features Target Cancellation (MFTC) test (accuracy score range from 0 to 1; higher score suggest better performance)'}, {'measure': 'Memory and learning', 'timeFrame': 'baseline and after 3 weeks', 'description': 'Selective Reminding Test - SRT: three scores are provided. 1) long term memory storage capacity (0-72), learning (0-72), delayed recall (0-12). Higher scores indicate better performance.'}, {'measure': 'Visuo-spatial abilities', 'timeFrame': 'baseline and after 3 weeks', 'description': 'Rey Figure - copy: test score range from 0 to 36, higher scores indicate better performance'}, {'measure': 'Inhibition', 'timeFrame': 'baseline and after 3 weeks', 'description': 'Stroop Test: higher time scores and error scores indicate worst inhibitory control'}, {'measure': 'Planning', 'timeFrame': 'baseline and after 3 weeks', 'description': 'Tower of London - ToL: higher time score ( 0-36) and accuracy score (0-36) indicate better performance'}, {'measure': 'Decision making', 'timeFrame': 'baseline and after 3 weeks', 'description': 'Balloon Analog Risk Task - BART (test score)'}], 'secondaryOutcomes': [{'measure': 'biomarkers of neurodegeneration', 'timeFrame': 'baseline and after 3 weeks', 'description': 'blood concentration (pg/ml)'}, {'measure': 'psychosocial wellbeing and satisfaction', 'timeFrame': 'baseline and after 3 weeks', 'description': 'Psychological General Well-Being Index (i.e., test scores)'}, {'measure': 'Quality of life (perceived psycho-physical and socio-economic wellbeing and satisfaction)', 'timeFrame': 'baseline and after 3 weeks', 'description': 'Quality of Life Scale: 16-items self-report scored from 1 - terrible to 7 - delighted (score range 16-112); higher score indicate higher wellbeing and satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'Sleep Disorder', 'Well-Being, Psychological', 'Cognitive Impairment', 'Cognitive Change', 'Neurologic Signs']}, 'descriptionModule': {'briefSummary': 'This observational study aims to evaluate multiple dimensions of health in patients with Obstructive Sleep Apnea Syndrome (OSAS), before and after three weeks of ventilotherapy.\n\nSpecifically, the study aims to identify pre- vs post-treatment differences in the following domains:\n\n* cognitive performance\n* blood expression of biomarkers related to neurodegeneration\n* psychosocial wellbeing\n\nThus, patients will complete the following evaluations before (T0) and after (T1) ventilotherapy:\n\n* neuropsychological standard assessment\n* blood sampling\n* psychosocial self-reported questionnaires', 'detailedDescription': "Obstructive Sleep Apnea Syndrome is associated with cognitive difficulties, low psychosocial wellbeing and quality of life; however, the possible beneficial contribution of ventilotherapy on these dimensions is not completely clear. Ventilotherapy restores brain oxygenation and improve rest, possibly increasing cognitive performances, psychosocial health and quality of life. Multidisciplinary approaches to the treatment of OSAS are rare, although recommended. Solid proof of OSAS comorbidities may encourage clinicians to adopt a holistic perspective of care, leading to better rehabilitative outcomes. Also, evidence of the beneficial effects of ventilotherapy could increase patients' compliance to ventilotherapy, which is generally low.\n\nThe study aims to evaluate multiple dimensions of patient's health before and after three weeks of ventilotherapy, focusing on the cognitive performance, the blood expression of biomarkers related to neurodegeneration, and individual's psychosocial wellbeing.\n\nOverall, it is expected improved cognitive performances and psychosocial wellbeing after ventilotherapy. Also, a reduction in the blood expression of biomarkers related to neurodegeneration (if found before the treatment) is hypothesized, although the limited research in this field requires cautious predictions.\n\nComprehensive evidence about OSAS comorbidity, beyond breath and sleep difficulties, is mandatory to design innovative multidisciplinary rehabilitative approaches in line with a holistic perspective of care. Effective multidisciplinary approaches are considered the gold standard in medical care, leading to better treatment outcomes and higher patients' satisfaction.\n\nBeyond the clear ethical implication of providing higher quality of treatment, multidisciplinary interventions also imply a shared responsibility of treatment, preventing from clinical misjudgments and professionals' burnout."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individual affected by OSAS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OSAS diagnosis (AHI \\> 5)\n* handedness: right\n\nExclusion Criteria:\n\n* previous ventilotherapy\n* neurological and/or neurodegenerative conditions\n* Personality disorders, autism spectrum disorders, schizophrenia, psychosis\n* sleep disorders comorbidities (eg., narcolepsy)'}, 'identificationModule': {'nctId': 'NCT06312956', 'acronym': 'MULTI-OSAS', 'briefTitle': "Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy", 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': "Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy", 'orgStudyIdInfo': {'id': '21C403'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Continuous Positive Airway Pressure Ventilotherapy', 'type': 'DEVICE', 'otherNames': ['CPAP'], 'description': 'Breathing support device during sleeping'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28824', 'city': 'Piancavallo', 'state': 'VCO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sofia Tagini, PhD', 'role': 'CONTACT', 'email': 's.tagini@auxologico.it', 'phone': '00393339915288'}], 'facility': 'IRCCS Istituto Auxologico Italiano', 'geoPoint': {'lat': 46.00932, 'lon': 8.62916}}], 'centralContacts': [{'name': 'Sofia Tagini, PhD', 'role': 'CONTACT', 'email': 's.tagini@auxologico.it', 'phone': '00393339915288'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}