Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-31 @ 1:22 AM
Study NCT ID:
NCT06320795
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2024-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-15', 'size': 2928638, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-13T09:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the accuracy of the clinical diagnosis of OSA', 'timeFrame': '6 Months', 'description': 'To evaluate the accuracy of the clinical diagnosis of OSA assisted by the home sleep study with SOUNDI against the clinical diagnosis assisted by the PSG as the reference standard.'}, {'measure': 'To evaluate the agreement between the Apnea Hypopnea Index (AHI) from the home sleep study with SOUNDI and the home sleep study with polysomnography (PSG)', 'timeFrame': '6 Months', 'description': 'To evaluate the agreement between the AHI from the home sleep study with SOUNDI and the home sleep study with PSG in patients being referred to sleep clinics with suggestive OSA symptoms.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'Day 1', 'description': 'Patient satisfaction were determined by interview.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['OSA']}, 'descriptionModule': {'briefSummary': 'This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of obstructive sleep apnea (OSA) syndrome in subjects with suspected diagnosis of sleep disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are able to understand the nature of the study and to give free informed consent\n* Must be over 20 and referred by medical staff for an overnight assessment for suspected sleep apnea\n\nExclusion Criteria:\n\n* Pregnancy\n* Pacemaker wearer\n* Allergies to any material of the device'}, 'identificationModule': {'nctId': 'NCT06320795', 'acronym': 'SOUNDI', 'briefTitle': 'Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocubica srl'}, 'officialTitle': 'Studio Prospettico Per la Validazione Clinica Del Dispositivo Medico Indossabile Soundi', 'orgStudyIdInfo': {'id': 'IT-MF-000031905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Soundi', 'description': 'Soundi device compared to overnight polysomnography', 'interventionNames': ['Device: SOUNDI']}], 'interventions': [{'name': 'SOUNDI', 'type': 'DEVICE', 'description': 'Continuous monitoring of vital signs for diagnosis and follow-up of sleep-disordered breathing in adults.', 'armGroupLabels': ['Soundi']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20149', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Carolina Lombardi, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituo Auxologico Italiano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocubica srl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}