Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT05115305
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2021-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prodigy, a Level 2 Sleep Study Device, Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Sleep Time', 'timeFrame': 'Concurrent measurement for one night', 'description': 'To compare Level 1 and Level 2 sleep tests on TST'}, {'measure': 'Apnea-Hypopnea Index', 'timeFrame': 'Concurrent measurement for one night', 'description': 'To compare Level 1 and Level 2 sleep tests on AHI'}, {'measure': 'Periodic Limb Movement Index', 'timeFrame': 'Concurrent measurement for one night', 'description': 'To visually compare Level 1 and Level 2 sleep tests on PLM'}], 'secondaryOutcomes': [{'measure': 'Signal Quality', 'timeFrame': 'Concurrent measurement for one night', 'description': 'To compare signal quality between Level 1 and Level 2 sleep tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prodigy'], 'conditions': ['Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '7726811', 'type': 'BACKGROUND', 'citation': 'Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.'}, {'pmid': '2748771', 'type': 'BACKGROUND', 'citation': 'Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.'}, {'pmid': '21532953', 'type': 'BACKGROUND', 'citation': 'Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.'}, {'pmid': '1798888', 'type': 'BACKGROUND', 'citation': 'Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.'}, {'pmid': '19639754', 'type': 'BACKGROUND', 'citation': 'Chasens ER, Ratcliffe SJ, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009 Jul;32(7):915-9. doi: 10.1093/sleep/32.7.915.'}, {'pmid': '21479777', 'type': 'BACKGROUND', 'citation': 'Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'The Prodigy system, developed by Cerebra Medical Ltd, allows for the generation of the same information in the home that is currently only obtained in in-laboratory studies.\n\nThe objective of the current study is to demonstrate that the signals obtained by this comprehensive, portable system are comparable to those obtained in in-laboratory studies.', 'detailedDescription': 'This study consists of obtaining standard polysomnography signals concurrently by the Prodigy 2 and by the standard commercial systems used in the Sleep Disorders Clinic (Alice G3) in Hamilton, ON and the St. Charles Sleep Disorders Center (Nihon Kohden) in Port Jefferson, NY. 42 patients will be recruited from each of the two sites, for a total of 84 patients. Questionnaires on demographics and mental health, including the Depression Anxiety Stress Scale-21, questionnaires on sleep and fatigue including Pittsburgh Sleep Quality Index, Insomnia Severity Index, and Epworth Sleepiness Scale and questionnaires on quality of life including the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) and the Euroquol 5D-5L will be completed online using a survey platform (Qualtrics or RedCap).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from patients referred to either sleep clinic to undergo a diagnostic sleep test.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients undergoing a diagnostic sleep test\n\nExclusion Criteria:\n\n* in-hospital patients\n* subjects who self-report a previous diagnosis of neuromuscular disorders, obesity hypoventilation, or severe lung disease\n* subjects who are not fluent in English, or who have special communication needs\n* subjects who have dementia/Alzheimer's disease\n* subjects with comorbid violent parasomnias\n* subjects requiring additional assistance or who have limited ability follow commands."}, 'identificationModule': {'nctId': 'NCT05115305', 'briefTitle': 'Prodigy, a Level 2 Sleep Study Device, Validation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cerebra Medical'}, 'officialTitle': 'Validation of a Level 2 Sleep Study Device', 'orgStudyIdInfo': {'id': 'ProdigyValidationStudy'}}, 'contactsLocationsModule': {'locations': [{'zip': '11777', 'city': 'Port Jefferson', 'state': 'New York', 'country': 'United States', 'facility': 'St Charles Sleep Disorders Center', 'geoPoint': {'lat': 40.94649, 'lon': -73.06927}}, {'zip': 'L8P 4M3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Sleep Disorders Clinic', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Amy Bender, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cerebra Medical'}, {'name': 'Raymond Gottschalk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamilton Sleep Disorders Clinic'}, {'name': 'Mohammad Amin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Charles Sleep Disorders Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cerebra Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}