Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT05230394
Status:
SUSPENDED
Last Update Posted:
2023-02-08
First Post:
2021-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Outcomes in Unattended and In- Lab Polysomnography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], '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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 194}}, 'statusModule': {'whyStopped': 'Funding Issues', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2021-12-30', 'studyFirstSubmitQcDate': '2022-02-04', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Functional Outcomes of Sleep Questionnaire', 'timeFrame': '4 months', 'description': 'Total Score scale ranges from 5-20, with higher scores representing better functioning'}, {'measure': 'Change in Epworth Sleepiness Scale', 'timeFrame': '4 months', 'description': 'Scale ranges from 0-24, with higher scores representing more sleepiness'}, {'measure': 'Continuous Positive Airway Pressure (CPAP) Adherence', 'timeFrame': '4 months', 'description': 'Percent of nights with CPAP \\> 4 hours/night'}, {'measure': 'Change in Calgary Sleep Apnea Quality of Life Index', 'timeFrame': '4 months', 'description': 'Total score ranges from 1-7, with a greater score indicating a lower effect of OSA on quality of life'}, {'measure': 'Rating of Physician Diagnostic Confidence', 'timeFrame': 'within 4 weeks of sleep study, after patient assessment by physician', 'description': 'Likert scale rating performed by physicians to assess confidence in diagnosis from data provided by the two systems, scale from 1-5 with higher values reflecting greater confidence'}, {'measure': 'Rating of Patient Satisfaction', 'timeFrame': 'Measured in morning following their sleep study', 'description': 'Likert scale rating of patient satisfaction for their sleep study experience, ranges from 1-7 with higher values reflecting greater satisfaction'}, {'measure': 'Cost between Level 1 and Level 2 tests based on equipment, facility, supply costs, and technician and physician service fees', 'timeFrame': 'After study conclusion, an average of up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnea', 'Hypersomnia']}, 'descriptionModule': {'briefSummary': 'This randomized controlled study will directly evaluate whether unattended polysomnography (level 2 sleep study) in individuals referred for sleep apnea or hypersomnia, including those with comorbidities of insomnia and sleep-related movement disorders, provides similar patient outcomes when compared to level 1 sleep studies.', 'detailedDescription': 'Individuals referred to the Sleep Disorder Centre with a major complaint of snoring or, apneas or hypersomnia, with at least one additional minor concern of snoring, apneas, restless leg syndrome or insomnia, will be considered for entry into the study. Using a randomized controlled trial design, study participants will be randomly assigned to either the intervention group who will undergo a full unattended polysomnography (level 2 home sleep study) using the Prodigy portable wireless sleep monitor or in-lab polysomnography (level 1 sleep study). Other aspects of care including the clinical assessment will be equivalent between groups. A randomly assigned sleep specialist physician will make treatment recommendations to the patient based on the sleep study results and determine the need for a subsequent testing (including repeat sleep studies) as part of each patient encounter. Physicians participating in the study will receive an introduction to the Odds Ratio Product (ORP) and training on its diagnostic potential. Diagnostic confidence using a 5 point Likert scale from 10% (very unsure) to 90% (very confident) will be assessed after each sleep study review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* referral for major concern of "snoring" or "apnea" or "hypersomnia" with additional minor concerns of "snoring", "apneas" "restless leg syndrome" or "insomnia"\n* willing to undergo a sleep study\n\nExclusion Criteria:\n\n* referrals where parasomnias, respiratory failure, narcolepsy listed as concerns\n* comorbid congestive heart failure, ischemic heart disease, arrhythmia, stroke, chronic obstructive pulmonary disease/respiratory failure, patients with a BMI 50 kg/m2\n* undergone a previous sleep study'}, 'identificationModule': {'nctId': 'NCT05230394', 'briefTitle': 'Patient Outcomes in Unattended and In- Lab Polysomnography', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cerebra Medical'}, 'officialTitle': 'Randomized Control Trial to Compare Patient Outcomes Following Unattended Polysomnography Versus In-lab Polysomnography for Sleep Apnea and Comorbid Sleep Disorders', 'orgStudyIdInfo': {'id': 'SDC Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Level 1 In Lab Polysomnography', 'interventionNames': ['Diagnostic Test: Attended Polysomnography in the Lab']}, {'type': 'EXPERIMENTAL', 'label': 'Level 2 In Home Polysomnography', 'interventionNames': ['Diagnostic Test: Unattended Polysomnography in the Home']}], 'interventions': [{'name': 'Attended Polysomnography in the Lab', 'type': 'DIAGNOSTIC_TEST', 'description': 'Using standard Level 1 polysomnography', 'armGroupLabels': ['Level 1 In Lab Polysomnography']}, {'name': 'Unattended Polysomnography in the Home', 'type': 'DIAGNOSTIC_TEST', 'description': "Using Cerebra's Prodigy system", 'armGroupLabels': ['Level 2 In Home Polysomnography']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3C 1A2', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Sleep Disorders Centre', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cerebra Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Manitoba', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}