Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-28 @ 11:18 AM
Study NCT ID:
NCT00497120
Status:
UNKNOWN
Last Update Posted:
2007-07-06
First Post:
2007-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Combined Surgical and Medical Approach in Mild Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D012913', 'term': 'Snoring'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'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': '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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086', 'term': 'Acetazolamide'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'lastUpdateSubmitDate': '2007-07-05', 'studyFirstSubmitDate': '2007-07-04', 'studyFirstSubmitQcDate': '2007-07-05', 'lastUpdatePostDateStruct': {'date': '2007-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Polysomnographic parameters'}], 'secondaryOutcomes': [{'measure': 'subjective sleepiness'}, {'measure': 'subjective snoring'}, {'measure': 'satisfaction'}]}, 'conditionsModule': {'keywords': ['sleep apnea', 'snoring', 'acetazolamide', 'uvulopalatopharyngoplasty', 'daytime sleepiness', 'upper airway'], 'conditions': ['Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate wether the adjuvant (postoperative) administration of acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients with mild sleep apnea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5 ≤ Apnea Hypopnea Index (AHI) \\< 20\n* Socially disturbing snoring: Visual Analogue Scale (VAS)snoring \\> 6/10\n* Based on clinical examination and polysomnography, patient is regarded eligible for uvulopalatopharyngoplasty (UPPP)\n\nExclusion Criteria:\n\n* Previous surgical treatment for sleep-disordered breathing.\n* Periodic Limb Movement Disorder (PLMD) with arousals and other reasons possibly explaining the Excessive Daytime Sleepiness (EDS) based on Epworth Sleepiness Scale (ESS).\n* Forced expiratory volume in 1 second (FEV1) \\< 80 % pred.\n* Echocardiography: ejectionfraction \\< 35 % or dyastolic dysfunction grade 2 or more.'}, 'identificationModule': {'nctId': 'NCT00497120', 'briefTitle': 'A Combined Surgical and Medical Approach in Mild Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'orgStudyIdInfo': {'id': 'EC 2/27/99'}}, 'armsInterventionsModule': {'interventions': [{'name': 'acetazolamide', 'type': 'DRUG'}, {'name': 'placebo', 'type': 'DRUG'}, {'name': 'uvulopalatopharygoplasty', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Olivier M Vanderveken, MD', 'role': 'CONTACT', 'email': 'olivier.vanderveken@uza.be'}, {'name': 'Olivier M Vanderveken, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Annick Devolder, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'centralContacts': [{'name': 'Wilfried De Backer, MD PhD', 'role': 'CONTACT', 'email': 'wilfried.debacker@ua.ac.be', 'phone': '+32 3 821 34 47'}], 'overallOfficials': [{'name': 'Wilfried De Backer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}}}}