Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT04232267
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2020-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Sleep Study Data to Assess Depressive Burden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 329}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-14', 'lastUpdatePostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Report assists in the detection of clinically significant depressive burden.', 'timeFrame': 'The study consists of 1 study visit (baseline).', 'description': 'Utilize PSG data and BDI-II to determine clinical depressive burden.'}, {'measure': 'Evaluate algorithm accuracy, sensitivity and specificity.', 'timeFrame': 'The study consists of 1 study visit (baseline).', 'description': 'Sensitivity: True Positive/BDI-II + (the percentage of BDI-II positives identified by MEB-001) Specificity: True Negative/BDI-II - (the percentage of BDI-II negatives identified by MEB-001)'}], 'secondaryOutcomes': [{'measure': 'Evaluate positive predictive value and negative predictive value in detecting clinically significant depressive burden.', 'timeFrame': 'The study consists of 1 study visit (baseline).', 'description': 'Positive predictive value: True Positive/MEB-001 + (the percentage of MEB-001 positive test results that agree with BDI-II) Negative predictive value: True Negative/MEB-001 - (the percentage of MEB-001 negative test results that agree with BDI-II)'}, {'measure': 'System reliability and internal consistency.', 'timeFrame': 'The study consists of 1 study visit (baseline).', 'description': 'The MEB-001 is able to assess clinically depressive burden compared to the BDI-II'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disorder', 'Depressive; Behavioral Disorder', 'Mood Disorders']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of the MEB-001 device in assessing physiological parameters that provide a clinically significant depressive burden screener. This study uses objective physiological markers from MEB-001 to estimate the clinically significant depressive burden as subjectively reported by the subject with the Beck Depression Inventory - II (BDI-II).', 'detailedDescription': 'This study evaluates the effectiveness of the MEB-001 device in assessing physiological parameters that provide a clinically significant depressive burden screener. This study uses objective physiological markers from MEB-001 to estimate the clinically significant depressive burden as subjectively reported by the subject with the BDI-II.\n\nThis is a two (2)-phase, non-significant risk, cross-sectional, naturalistic, single-arm, multi-center study conducted under a common protocol and designed to:\n\nPhase 1: MEB-001 algorithm development (software medical device). Phase 2: Evaluate the effectiveness of the MEB-001 device in assessing physiological parameters that provide clinically significant depressive burden screener.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who are at least 18 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbances and sign an informed consent form (ICF) will be eligible to participate in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is age ≥18 years and ≤75 years.\n* Subject is willing and able to provide consent.\n* Subject has the ability to read and understand the instructions for the study.\n* Subject is willing to adhere to study procedures.\n* Subject is willing to undergo full night PSG study, as prescribed.\n\nExclusion Criteria:\n\n* Subject has a pacemaker.\n* Subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).'}, 'identificationModule': {'nctId': 'NCT04232267', 'acronym': 'SADB', 'briefTitle': 'Analysis of Sleep Study Data to Assess Depressive Burden', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medibio Limited'}, 'officialTitle': 'Development and Validation of an Algorithm to Identify a Clinically Significant Depressive Burden in Individuals Referred to Sleep Clinics for Polysomnography (PSG) Assessment (Sleep Analysis of Depressive Burden - SADB)', 'orgStudyIdInfo': {'id': 'CIP-0018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients prescribed Polysomnology (PSG - sleep study)', 'description': 'Patients that are at least 18 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbance.', 'interventionNames': ['Device: MEB-001']}], 'interventions': [{'name': 'MEB-001', 'type': 'DEVICE', 'description': 'Software medical device used to aid in the screening of patients with potential depressive burden symptoms.', 'armGroupLabels': ['Patients prescribed Polysomnology (PSG - sleep study)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55434', 'city': 'Blaine', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Restore Sleep Clinic', 'geoPoint': {'lat': 45.1608, 'lon': -93.23495}}, {'zip': '55441', 'city': 'Plymouth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Lakeland Sleep and CPAP', 'geoPoint': {'lat': 45.01052, 'lon': -93.45551}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Solutions', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43123', 'city': 'Grove City', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Solutions', 'geoPoint': {'lat': 39.88145, 'lon': -83.09296}}, {'zip': '43026', 'city': 'Hilliard', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Solutions', 'geoPoint': {'lat': 40.0334, 'lon': -83.15825}}], 'overallOfficials': [{'name': 'Melissa Bruner', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medibio Limited'}, {'name': 'Archie Defillo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medibio Limited'}, {'name': 'Archie Defillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medibio Limited'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share the participant data to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medibio Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}