Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-02 @ 6:09 AM
Study NCT ID:
NCT06916858
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2024-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of OSA and Diagnostic Accuracy of Type 3 Home Sleep Test in Difficult-to-treat Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'mask the result of home sleep test and Polysonography'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2025-04-01', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of OSA in patients with difficult-to-treat asthma', 'timeFrame': 'up to 4 months', 'description': 'prevalence of OSA in patients with difficult-to-treat asthma'}], 'secondaryOutcomes': [{'measure': 'assess the accuracy of type 3 home sleep apnea test (HSAT)', 'timeFrame': 'up to 1 months', 'description': 'number of participant who have same diagnosed OSA with type 3 HSAT compare to type 1 sleep test\n\n* AHI\n* ODI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'OSA', 'HSAT', 'home sleep test'], 'conditions': ['OSA']}, 'descriptionModule': {'briefSummary': 'cross sectional cohort study enroll Patients diagnosed with difficult-to-treat asthma, aged over 18 years, and experiencing persistent symptoms as assessed by the Asthma Control Test (ACT) underwent type 1 in-laboratory polysomnography and type 3 HSAT within 1 month apart'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* difficult-to-treat asthma .\n* Patients aged 18 years or older\n\nExclusion Criteria:\n\n* Patients or volunteers unable to undergo type 1 and type 3 sleep studies,\n* Patients with symptoms compatible with other sleep disorders,\n* Patients with a history of or current stroke or transient ischemic attack and Other chronic respiratory diseases.\n* Patients diagnosed with obstructive sleep apnea'}, 'identificationModule': {'nctId': 'NCT06916858', 'briefTitle': 'Prevalence of OSA and Diagnostic Accuracy of Type 3 Home Sleep Test in Difficult-to-treat Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Prevalence of OSA and Diagnostic Accuracy of Type 3 Home Sleep Test in Difficult-to-treat Asthma', 'orgStudyIdInfo': {'id': '0722/66'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'difficult to treat asthma', 'description': 'difficult to treat asthma run HST and PSG', 'interventionNames': ['Device: home sleep test']}], 'interventions': [{'name': 'home sleep test', 'type': 'DEVICE', 'otherNames': ['polysonography'], 'description': 'Apnealink air', 'armGroupLabels': ['difficult to treat asthma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Tidarat Somreusean', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}