Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-02 @ 1:46 AM
Study NCT ID:
NCT06930404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Data Collection Study to Review Novel Methods for Diagnosing Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of measurement and obstructive sleep apnea status', 'timeFrame': '1 day', 'description': '\\- Area under the ROC curve (AUC) for each modality and their combinations in predicting moderate/severe OSA (AHI ≥15).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diagnosis', 'screening'], 'conditions': ['Obstructive Sleep Apnea (OSA)']}, 'descriptionModule': {'briefSummary': 'This study will collect data on a range of signals such as facial scans, videos (including speaking, blinking and swallowing) and heart rate variability to assess whether any of these measures are useful for diagnosing obstructive sleep apnea'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults who are being tested for obstructive sleep apnea', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged \\>= 18 Ability to read and comprehend English\n\nExclusion Criteria:\n\n* Previous diagnosis of OSA\n* Respiratory diseases (such COPD, lung cancer, fibrosis of the lungs, lung injury)\n* Subjects who are or may be pregnant, breastfeeding or within 6 weeks postpartum (which may impact HRV temporarily)\n* Subjects with a pacemaker'}, 'identificationModule': {'nctId': 'NCT06930404', 'acronym': 'Ignite', 'briefTitle': 'Data Collection Study to Review Novel Methods for Diagnosing Obstructive Sleep Apnea', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Innovation and Growth Network for Insightful Trends and Evaluation - Data Collection Study', 'orgStudyIdInfo': {'id': 'MA08042025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'People being investigated for obstructive sleep apnea', 'description': 'People who are undergoing testing (home sleep testing or polysomnography) due to suspicion of sleep apnea will be invited to take part', 'interventionNames': ['Other: facial scans, videos and heart rate variability measurements']}], 'interventions': [{'name': 'facial scans, videos and heart rate variability measurements', 'type': 'OTHER', 'description': 'Ignite app to collect data (videos, photos and heart rate variability)', 'armGroupLabels': ['People being investigated for obstructive sleep apnea']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alison Wimms, PhD', 'role': 'CONTACT', 'email': 'alison.wimms@resmed.com.au', 'phone': '+61466015420'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}