Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-06 @ 11:46 AM
Study NCT ID:
NCT06851351
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2025-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Restriction in Prader-Willi Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011218', 'term': 'Prader-Willi Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D000096803', 'term': 'Imprinting Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013147', 'term': 'Spirometry'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rib cage contribution to ventilation', 'timeFrame': 'At enrollment', 'description': 'Percentage rib cage contribution to ventilation as measured by optoelectronic plethysmography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thoraco-abdominal volumes', 'lung volumes', 'optoelectronic plethysmography', 'respiratory manoeuvres', 'posture'], 'conditions': ['Prader-Willi Syndrome']}, 'descriptionModule': {'briefSummary': 'The main aim of this study is therefore to evaluate the impact of Prader Willi Syndrome (PWS) on lung and thoracoabdominal volumes, respiratory muscle strength and awake ventilatory pattern, and to quantify and localize the PWS-induced respiratory restriction.', 'detailedDescription': 'The aim is to study lung function in obese PWS patients using both volitional (spirometry, nitrogen wash-out, and maximal pressure measurements (MIP and MEP)) and non-volitional (awake ventilatory pattern by opto-electron plethysmography) tests, both in sitting and supine positions.\n\nSpirometry, nitrogen wash-out, and MIP and MEP measurements are comprehensive assessments, while optoelectronic plethysmography allows restriction location through accurate measurement of thoracoabdominal volumes.\n\nThe results of the study could provide useful information about the calculation of the volumes enclosed by the grid of markers (in particular, the volume of the rib cage, which reflects the action of the intercostal muscles, the volume of the abdomen, which reflects the action of the diaphragm in the inspiratory phase and of the abdominal muscles during exhalation and their sum, which represents the total variation of the thoraco-abdominal wall. All these finds could be useful for respiratory rehabilitation protocols for obese PWS patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Prader Willi Syndrome and obesity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients with Prader Willi Syndrome\n\nInclusion Criteria:\n\n* Age 20-50 years\n* Prader Willi Syndrome\n* Body Mass Index \\> 30 kg/m2\n\nExclusion Criteria:\n\n* Lack of signed consent form\n\nControl subjects\n\nInclusion Criteria:\n\n* Age 20-50 years\n* Body Mass Index \\< 25 kg/m2\n\nExclusion Criteria:\n\n* Lack of signed consent form'}, 'identificationModule': {'nctId': 'NCT06851351', 'acronym': 'RESPIPWS', 'briefTitle': 'Respiratory Restriction in Prader-Willi Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Study of Respiratory Restriction in Patients With Prader-Willi Syndrome', 'orgStudyIdInfo': {'id': '01C318'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Prader Will syndrome and BMI > 30 kg/m2', 'interventionNames': ['Diagnostic Test: Spirometry and optoelectronic plethysmography']}, {'label': 'Control subjects with BMI < 25 kg/m2', 'interventionNames': ['Diagnostic Test: Spirometry and optoelectronic plethysmography']}], 'interventions': [{'name': 'Spirometry and optoelectronic plethysmography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Spirometry for respiratory function and optoelectronic plethysmography for respiratory pattern during wakefulness', 'armGroupLabels': ['Control subjects with BMI < 25 kg/m2', 'Patients with Prader Will syndrome and BMI > 30 kg/m2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28824', 'city': 'Oggebbio', 'state': 'Verbania', 'country': 'Italy', 'facility': 'Istituto Auxologico Italiano IRCCS, Site Piancavallo', 'geoPoint': {'lat': 45.99088, 'lon': 8.64663}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}