Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-01-28 @ 3:45 PM
Study NCT ID:
NCT01223859
Status:
COMPLETED
Last Update Posted:
2010-10-19
First Post:
2010-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012913', 'term': 'Snoring'}], 'ancestors': [{'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-18', 'studyFirstSubmitDate': '2010-10-18', 'studyFirstSubmitQcDate': '2010-10-18', 'lastUpdatePostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS', 'timeFrame': '3 months postoperatively', 'description': 'Visual analogue scale snoring patient and bed partner'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Radiofrequency, ablation, RFA, RFTA, RFITT, soft palate.'], 'conditions': ['Snoring']}, 'referencesModule': {'references': [{'pmid': '21311985', 'type': 'DERIVED', 'citation': 'Back LJ, Koivunen P, Pyykko I, Stene BK, Makitie AA. The impact of pretreatment assessment of oropharynx on interstitial soft palate radiofrequency surgery outcome--a multi-center study in patients with habitual snoring. Sleep Breath. 2012 Mar;16(1):199-204. doi: 10.1007/s11325-011-0490-4. Epub 2011 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in the treatment of habitual snoring. The decision making process in the management of habitual snoring would benefit from diagnostic guidelines for oropharyngeal findings. The aim was to investigate the correlation of systematic clinical pretreatment oropharyngeal examination scores with the efficacy of interstitial RF surgery of SP in a multi-center study', 'detailedDescription': 'TABLE 1. The inclusion and exclusion criterion used for the multicenter study.\n\nCriteria Inclusion Exclusion \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nAge (years) 18-65 \\< 18, \\> 65\n\nHabitual snoring yes no Excessive daytime sleepiness no yes\n\nBMI (kg/m2) \\< 28 \\> 28\n\nAHI (events/hour) \\< 15 \\> 15\n\nOverjet (mm) \\< 5 \\> 5 Clinical suspicion of obstruction no yes at base of tongue\n\nSize of palatine tonsils (grade) 0-II III-IV\n\nNose breathing problems no yes\n\nPharyngeal tonsil hypertrophy no yes\n\nA bed partner to assess snoring yes no\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nAbbreviations: BMI = body mass index, AHI = apnea-hypopnea index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'TABLE 1. The inclusion and exclusion criterion used for the multicenter study.\n\nCriteria Inclusion Exclusion \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nAge (years) 18-65 \\< 18, \\> 65\n\nHabitual snoring yes no Excessive daytime sleepiness no yes\n\nBMI (kg/m2) \\< 28 \\> 28\n\nAHI (events/hour) \\< 15 \\> 15\n\nOverjet (mm) \\< 5 \\> 5 Clinical suspicion of obstruction no yes at base of tongue\n\nSize of palatine tonsils (grade) 0-II III-IV\n\nNose breathing problems no yes\n\nPharyngeal tonsil hypertrophy no yes\n\nA bed partner to assess snoring yes no\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nAbbreviations: BMI = body mass index, AHI = apnea-hypopnea index.'}, 'identificationModule': {'nctId': 'NCT01223859', 'briefTitle': 'Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Helsinki'}, 'officialTitle': 'The Impact of Pretreatment Assessment of Oropharynx on Interstitial Soft Palate Radiofrequency Surgery Outcome - a Multi-center Study in Patients With Habitual Snoring', 'orgStudyIdInfo': {'id': 'lefa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Interstitial soft palate RF surgery', 'interventionNames': ['Procedure: Interstitial soft palate surgery']}], 'interventions': [{'name': 'Interstitial soft palate surgery', 'type': 'PROCEDURE', 'otherNames': ['RFA', 'RFTA'], 'description': 'Soft palate RF surgery in local anaesthesia', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Leif JJ Bäck, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Dept of ORL HN Surg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Helsinki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany', 'class': 'UNKNOWN'}, {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Leif Bäck MD, PhD', 'oldOrganization': 'Dept of ORL HN Surgery'}}}}