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| Descriptive Information Fields | |||||
| Brief Title † | Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea | ||||
| Official Title † | Pillar Palatal Implant System Multi-Institutional, Randomized Placebo-Controlled Study for Obstructive Sleep Apnea | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. In 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Daytime Sleepiness (ESS) Apnea/Hypopnea Index (AHI) |
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| Secondary Outcome Measure † | Sleep Related Quality of Life (FOSQ) Reaction Time Testing (PVT) Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat) |
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| Condition † | Obstructive Sleep Apnea | ||||
| Intervention † | Device: Pillar Palatal Implants | ||||
| MEDLINE PMIDs | |||||
| Links | Manufacturer's website for more information on Pillar Implants ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 100 | ||||
| Start Date † | October 2005 | ||||
| Completion Date | October 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00307957 | ||||
| Organization ID | 05-08-14-1 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of Cincinnati | ||||
| Collaborators †† | Restore Medical, Inc. | ||||
| Investigators † |
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| Information Provided By | University of Cincinnati | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | March 27, 2006 | ||||
| Last Updated Date | December 10, 2007 | ||||