Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:40 PM
Study NCT ID:
NCT00399451
Status:
UNKNOWN
Last Update Posted:
2006-11-22
First Post:
2006-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012913', 'term': 'Snoring'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2009-06'}, 'lastUpdateSubmitDate': '2006-11-20', 'studyFirstSubmitDate': '2006-11-13', 'studyFirstSubmitQcDate': '2006-11-13', 'lastUpdatePostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.'}], 'secondaryOutcomes': [{'measure': 'Arterial oxygen saturation (SaO2) and body mass index (BMI)will be measured on polysomnography'}]}, 'conditionsModule': {'keywords': ['Sleep Apnea,Obstructive', 'apnea-hypopnea index (AHI)', 'polidocanol', 'sclerotherapy', 'pharynges'], 'conditions': ['Apnea', 'Snoring']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of pharynx for OSAS \\& SS,to reduce pharyngeal compliance.', 'detailedDescription': 'Polidocanol submucous sclerosis in the part of pharynges with 1% polidocanol injection.The injection should be in the retropharyngeal submucosa and lateral pharyngeal bands and lateral pharyngeal submucosa and in front submucosa of soft palate.The injection is multi-point,and each point injection is 0.3\\~0.5ml;the total quantity/each time is not more than 5ml.Every patient have to be treated about 1\\~2 time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OSAS \\& SS which palatopharyngeal collapse.\n\nExclusion Criteria:\n\n* obstructive sleep apnea syndrome (osas) \\& snoring subjects (ss),which anatomic narrow result in.'}, 'identificationModule': {'nctId': 'NCT00399451', 'briefTitle': 'Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS)', 'organization': {'class': 'OTHER', 'fullName': 'Liaoyang Central Hospital'}, 'officialTitle': 'Preliminary Study on Submucous Sclerosis of Pharynges With 1% Polidocanol to Treat Obstructive Sleep Apnea (OSA) & Snoring Subjects (SS)', 'orgStudyIdInfo': {'id': 'LYZXYY06002'}, 'secondaryIdInfos': [{'id': 'ACTRNO12606000444583'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Polidocanol Sclerotherapy', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hongyan Chen, MB', 'role': 'CONTACT', 'email': 'lychy2006@yahoo.com.cn', 'phone': '+86-0419-3221423'}], 'overallOfficials': [{'name': 'Youliang YIN, MB', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaoyang Central Hospital', 'class': 'OTHER'}}}}