Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-05-24 @ 12:02 PM
Study NCT ID:
NCT03285451
Status:
UNKNOWN
Last Update Posted:
2017-09-18
First Post:
2017-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Induced Submental Ultrasound in Obstructive Sleep Apnea Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2017-09-14', 'studyFirstSubmitQcDate': '2017-09-14', 'lastUpdatePostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The value of drug induced sleep ultrasonography in patients with obstructive sleep apnea', 'timeFrame': 'May, 2017 to Aug, 2017', 'description': 'In this study, we proposed a novel method, drug induced sleep ultrasonography (DISU), which was applied to measure the tongue base thickness in OSA patients during drug induced sleep, so as to further understand the impact of dynamic change of tongue base thickness in OSA patients.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Submental ultrasound, Obstructive sleep apnea'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'In this study, submental ultrasound during awake and simultaneous under Drug-induced sleep endoscopy is applied in the diagnostic workup of obstructive sleep apnea patients. The aim is to assess the tongue base thickness during awake and sleep with different head positions. By correlation with Drug-induced sleep endoscopy findings, more parameters could be used for evaluation and management of upper airway collapse in obstructive sleep apnea patients.', 'detailedDescription': 'Obstructive sleep apnea (OSA) is a syndrome characterized by recurrent episodes of apnea and hypopnea during sleep that are caused by repetitive upper airway (UA) collapse and often result in decreased blood oxygen levels and arousal from sleep. Successful treatment lies in precise mapping the site of airway narrowing.\n\nDrug-induced sleep endoscopy (DISE) is a well described modality to mimic the dynamic change of UA in OSA patients during natural sleep. Nevertheless, the tongue base thickness (TBT), one of the important anatomic factors in OSA, is hard to evaluate under this method. Recently, submental ultrasound (US), the noninvasive and convenient tool, has been widely applied to measure the TBT in awake OSA patients, so as to predict the severity and relationship with UA collapse. However, few evidence has addressed the relationship between UA collapse and the TBT in different head positions, awake and sleep period In this study, submental US during awake and drug induced sleep period is applied in the diagnostic workup of OSA patients. By correlation with DISE findings, more parameters could be used for evaluation and management of upper airway collapse in OSA patients.\n\nKey Words: Submental ultrasound, Obstructive sleep apnea, Drug-induced sleep endoscopy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obstructive sleep apnea patients, age between 20-70 without severe heart, lung, liver, and kidney comorbidity or propofol or dexmedetomidine allergies', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obstructive sleep apnea patients, age between 20-70\n\nExclusion Criteria:\n\n* severe heart, lung, liver, and kidney comorbidity propofol or dexmedetomidine allergies (albeit rare)'}, 'identificationModule': {'nctId': 'NCT03285451', 'briefTitle': 'Drug Induced Submental Ultrasound in Obstructive Sleep Apnea Patients', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation'}, 'officialTitle': 'Correlative Analysis of Upper Airway Collapse in Sleep Endoscope and Submental Ultrasound', 'orgStudyIdInfo': {'id': '06-X07-017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'submental ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Submental ultrasound, the noninvasive and convenient tool, has been widely applied to measure the tongue base thickness in patients with obstructive sleep apnea, so as to predict the severity and relationship with upper airway collapse.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '231', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ming-Chin Lan, MD', 'role': 'CONTACT', 'email': 'lanmingchin@gmail.com', 'phone': '+886920734552'}], 'facility': 'Taipei Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ming-Chin Lan, MD', 'role': 'CONTACT', 'email': 'lanmingchin@gmail.com', 'phone': '+886920734552'}], 'overallOfficials': [{'name': 'Ming-Chin Lan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Taipei Tzu Chi Hospita l Buddhist Tzu Chi Medical Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}