Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
Study NCT ID:
NCT00307957
Status:
COMPLETED
Last Update Posted:
2007-12-12
First Post:
2006-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], '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': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-10', 'studyFirstSubmitDate': '2006-03-27', 'studyFirstSubmitQcDate': '2006-03-27', 'lastUpdatePostDateStruct': {'date': '2007-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daytime Sleepiness (ESS)'}, {'measure': 'Apnea/Hypopnea Index (AHI)'}], 'secondaryOutcomes': [{'measure': 'Sleep Related Quality of Life (FOSQ)'}, {'measure': 'Reaction Time Testing (PVT)'}, {'measure': 'Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat)'}]}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'Daytime Sleepiness', 'Pillar Palatal Implants'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.restoremedical.com', 'label': "Manufacturer's website for more information on Pillar Implants"}]}, 'descriptionModule': {'briefSummary': 'The Pillar palatal implant procedure is a minimally invasive and commercially available treatment for mild to moderate obstructive sleep apnea (OSA) in the United States and Europe. The implants are placed into the soft area in the roof of the mouth providing support to the soft palate. This research is being done to compare daytime sleepiness and sleep related quality of life after palatal implants.', 'detailedDescription': 'Patients will be enrolled into the study based on sleep study results, a physical exam and inclusion/exclusion criteria. Once enrolled, patients are randomized into either the Pillar palatal implant group or a placebo/sham group.\n\nIn both cases, patients come into the office for placement of the implants. This is an outpatient procedure. Patients are followed at one week, one month and 3 months. At each follow-up visit, patients will undergo a physical exam and complete questionnaires related to sleep and quality of life. Patients will also undergo reaction time testing on hand-held device similar to a pocket video game. At the three month visit, patients will return to the sleep lab for another sleep study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Body Mass Index equal to 32 or less\n* Apnea-Hypopnea Index greater than/equal to 10 and less than/equal to 30\n* Symptoms of daytime sleepiness\n\nExclusion Criteria:\n\n* Septal deviation or nasal obstruction\n* Nasal polyps\n* Severe seasonal allergies\n* Soft palate length insufficient to accommodate implants\n* Fujita Modified Mallampati Class 3\n* Large tonsils\n* Lingual tonsil hypertrophy\n* Hypopharyngeal obstruction\n* Previous pharyngeal surgery\n* Previous upper respiratory tract cancer or radiation therapy\n* Active respiratory tract infection\n* Dysphagia or speech disorder\n* Neurologic disorder\n* Unstable psychiatric disorder\n* Pregnant or breastfeeding\n* History of falling asleep driving or MVA due to sleepiness\n* Currently on CPAP therapy or other device for OSA\n* Other sleep disorders'}, 'identificationModule': {'nctId': 'NCT00307957', 'briefTitle': 'Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '05-08-14-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pillar Palatal Implants', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'University of Indiana Medical Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '45267-0528', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Ear, Nose and Throat Specialists', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '53022', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Department of OTO-HNS Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'David L Steward, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ear, Nose and Throat Specialists'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic Xomed, Inc.', 'class': 'INDUSTRY'}]}}}