Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 2:39 PM
Study NCT ID:
NCT04557293
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2020-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effort-based Decision-making and CPAP Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D001049', 'term': 'Apnea'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Memory', 'timeFrame': 'Change will be assesd before starting CPAP and after six months of CPAP treatment', 'description': 'Short and Long-term memory will be assessed with Digit span and California verbal learning test'}, {'measure': 'Executive Function', 'timeFrame': 'Change will be assesd before starting CPAPT and after six months of CPAP treatment', 'description': 'attentional and executive functioning will be assessed with Test of Attentional Performance (TAP)'}, {'measure': 'Planning', 'timeFrame': 'Change will be assesd before starting CPAPT and after six months of CPAP treatment', 'description': 'Planning will be assessed with Tower of London'}, {'measure': 'Response inhibition', 'timeFrame': 'Change will be assesd before starting CPAPT and after six months of CPAP treatment', 'description': 'Will be assessed with Test Go-nogo'}, {'measure': 'Efforth decision making', 'timeFrame': 'Change will be assesd before starting CPAPT and after six months of CPAP treatment', 'description': 'Will be assesses with Rapid Serial Visual Presentation (RSVP)'}], 'secondaryOutcomes': [{'measure': 'Effect of CPAP treatment on memory', 'timeFrame': 'After six month of CPAP use', 'description': 'Administration of Digit span and California verbal Learning test'}, {'measure': 'Effect of CPAP treatment on executive function', 'timeFrame': 'After six month of CPAP use', 'description': 'Administration of Test attentional Performance'}, {'measure': 'Effect of CPAP on planning', 'timeFrame': 'After six month of CPAP use', 'description': 'Adimnistration of Tower of London Test'}, {'measure': 'Effect of CPAP on Response inhibition', 'timeFrame': 'After six month of CPAP use', 'description': 'administration of go no go Test'}, {'measure': 'Effect of CPAP on effort decision making', 'timeFrame': 'After six month of CPAP use', 'description': 'Administration of Rapid Serial Visual Presentation (RSVP) test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['apnoea', 'effort based decision making', 'rehabilitation', 'adherence'], 'conditions': ['Obstructive Sleep Apnea', 'Adherence']}, 'referencesModule': {'references': [{'pmid': '30736887', 'type': 'BACKGROUND', 'citation': 'Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of Adult Obstructive Sleep Apnea with Positive Airway Pressure: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2019 Feb 15;15(2):335-343. doi: 10.5664/jcsm.7640.'}, {'pmid': '21037021', 'type': 'BACKGROUND', 'citation': 'Canessa N, Castronovo V, Cappa SF, Aloia MS, Marelli S, Falini A, Alemanno F, Ferini-Strambi L. Obstructive sleep apnea: brain structural changes and neurocognitive function before and after treatment. Am J Respir Crit Care Med. 2011 May 15;183(10):1419-26. doi: 10.1164/rccm.201005-0693OC. Epub 2010 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnoea is the most common sleep disorder in general population, and is often associated with cognitive deficit, mood disorders, hypertension, diabetes mellitus, excessive daytime somnolence, nicturia and an increased cardiovascular and metabolic risk. The gold standard of treatment is Continuous Positive Airway Pressure (CPAP), but the adherence is often poor. The aim of our study is to investigate the effort based-decision making in patients with OSA, pre and post CPAP treatment, as a possible cause of poor adherence.', 'detailedDescription': 'Obstructive sleep apnea is a very common disease in general population (24% males; 9% females), characterized by frequent partial or total upper-airway collapse, intermittent hypoxia, arousal from sleep, change in blood pressure, excessive daytime sleepiness, cardiovascular and metabolic diseases, psychological and cognitive consequences. The gold standard treatment is Continuous Positive Airway Pressure (CPAP), but the adherence is often poor. Poor therapy adherence might be partially explained by executive deficits, decreasing the ability to plan and pursue longsighted behaviors entailing immediate costs/efforts. We investigate the cognitive function, in particular effort based-decision making and the relationship with excessive daytime somnolence and other cognitive function in a group of OSA patients and in control group. We assess cognitive function in OSA patients at the diagnosis moment and after six months of CPAP use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* AHI±15\n\nExclusion Criteria:\n\n* BMI ≥ 35 Kg/m2\n* MMSE \\<24\n* Complex sleep apnoea\n* Sleep disorder\n* Psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT04557293', 'briefTitle': 'Effort-based Decision-making and CPAP Adherence', 'organization': {'class': 'OTHER', 'fullName': 'Istituti Clinici Scientifici Maugeri SpA'}, 'officialTitle': 'Effort-based Decision-making as a Possible Predictor of Poor Adherence to CPAP Treatment in Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '2425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP Treatment', 'description': 'Patients with OSA will undergo cognitive assessment before starting CPAP treatment and after six months of CPAP use.', 'interventionNames': ['Device: Continuous Positive Airway Pressure (CPAP) treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'We will enrol a control group of subjects without sleep disorders and comparable to OSA patients for age and schooling. Control group will undergo cognitive assessment.'}], 'interventions': [{'name': 'Continuous Positive Airway Pressure (CPAP) treatment', 'type': 'DEVICE', 'description': 'Treatment of Obstructive sleep apnoea syndrome with CPAP', 'armGroupLabels': ['CPAP Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'ICS Maugeri Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Nicola Canessa, PhD', 'role': 'CONTACT', 'email': 'nicola.canessa@icsmaugeri.it', 'phone': '+39 0382 375845'}], 'overallOfficials': [{'name': 'Nicola Canessa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituti Clinici Scientifici Maugeri - Scuola superiore IUSS Pavia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituti Clinici Scientifici Maugeri SpA', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Universitario di Studi Superiori Pavia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}