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| Name | Class |
|---|---|
| Medtronic Xomed, Inc. | INDUSTRY |
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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pillar Palatal Implants | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime Sleepiness (ESS) | ||
| Apnea/Hypopnea Index (AHI) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Related Quality of Life (FOSQ) | ||
| Reaction Time Testing (PVT) | ||
| Other polysomnographic parameters (AI, HI, RERArl, Arl, LSat) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L Steward, MD | University Ear, Nose and Throat Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Indiana Medical Center | Indianapolis | Indiana | United States | |||
| University Ear, Nose and Throat Specialists |
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| Label | URL |
|---|---|
| Manufacturer's website for more information on Pillar Implants | View source |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Cincinnati |
| Ohio |
| 45267-0528 |
| United States |
| Department of OTO-HNS Medical College of Wisconsin | Milwaukee | Wisconsin | 53022 | United States |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |