Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
Study NCT ID:
NCT03590795
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2018-07-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-20', 'studyFirstSubmitDate': '2018-07-10', 'studyFirstSubmitQcDate': '2018-07-10', 'lastUpdatePostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The primary analysis will calculate the agreement between the physician's primary diagnosis (considered the gold standard) and the Sleep survey's primary classification", 'timeFrame': '1 day', 'description': "The primary analysis will calculate the agreement between the physician's primary diagnosis (considered the gold standard) and the Sleep survey's primary classification. Percent agreement will be calculated for each sleep problem, and for the study sample as a whole, including the 95% confidence interval (CI)."}], 'secondaryOutcomes': [{'measure': "Percent agreement will be calculated to determine how often the survey includes the physician's primary diagnosis as one of its classifications.", 'timeFrame': '1 day', 'description': "Percent agreement will be calculated to determine how often the survey includes the physician's primary diagnosis as one of its classifications. This will be calculated for each sleep problem, and for the study sample as a whole, including the 95% confidence interval."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': 'Sleep is an important contributing factor to people\'s health. However, over one third of the general population has sleep complaints, causing both health related problems, and economic impact. Many do not think their problem sleep is serious enough to consult a physician (primary care or sleep specialist). For a selection of this population, self-tracking devices can be a solution, but these trackers are often activity based and therefore lacking in their capacity to give insight into underlying causes of poor quality sleep and daytime fatigue.\n\nA new options for these confused sleeper is an online questionnaire, developed by Philips and Cooperative Research Center (CRC) for Alertness, Safety and Productivity Imagine a troubled sleeper awake at 3 am, they search "Why can\'t I sleep?" and find the survey. From there the user takes the sleep survey, which has the ability to assess their most likely sleep problem or problems from a list of seven sleep problem categories based upon their responses. At the end of the survey, participants will get information about which problem category they will fall into, and the level of certainty around that.\n\nThe purpose of the study is to determine the accuracy of the questionnaire in identifying the correct sleep problem when compared with the assessment of a sleep physician in a clinical sleep center. We hope to enroll 200 participants which was based upon an Initial power analyses were completed using pilot data, assuming accuracy rates of 70, 80, and 90% and a total sample size of 200. The intervals would be about ± 4.5% (for 90%) to ± 7% (for 70%). Participants will complete the survey, be blinded to the results, and then have a consultation with a sleep physician who will make an independent assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be those who are new patients to the sleep lab or those recruited from a central recruiter that may or may not have sleep issues.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20-75 years old.\n* Able to provide written informed consent\n* Able to read, write and speak English\n\nExclusion Criteria:\n\n* Has seen a sleep physician previously for formal clinical evaluation of a potential sleep problem.\n* Is being treated for any sleep disorder.\n* Has a major psychiatric disorder that is unstable at the time of evaluation.\n* Has a major medical condition likely to contribute to and thus to confound any sleep problem (congestive heart failure, severe Chronic Obstructive Pulmonary Disease (COPD), a pain syndrome, etc).'}, 'identificationModule': {'nctId': 'NCT03590795', 'briefTitle': 'VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Respironics'}, 'officialTitle': 'VISC-Q Trial (Validation of an Online Sleep Characterization Questionnaire)', 'orgStudyIdInfo': {'id': 'SRC-AI-SC-2018-10138'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Problem Sleepers', 'description': 'Those individuals that have self identified as having a unspecified sleep problem will take the sleep survey.', 'interventionNames': ['Other: Sleep survey']}], 'interventions': [{'name': 'Sleep survey', 'type': 'OTHER', 'description': 'The Sleep survey was created by the Collaborative Research Center (CRC), a joint effort of the Australian Government, Academia and Industry \\[including Philips\\]).', 'armGroupLabels': ['Problem Sleepers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35213', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Sleep Disorders Center of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '33971', 'city': 'Lehigh Acres', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Lung & Sleep Associates', 'geoPoint': {'lat': 26.62535, 'lon': -81.6248}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'NeuroTrials Research Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Sleep and Wake Disorders', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '63143', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clayton Sleep Institute', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sleep Therapy and Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'timeFrame': 'After final study analysis data will be available for up to 5 years.', 'ipdSharing': 'YES', 'description': 'De-identified data sets will be shared with academic institutions for development purposes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Respironics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cooperative Research Center (CRC) for Alertness, Safety and Productivity', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}