Study to Determine the Effectiveness of Pillar Palatal Implants to Treat Obstructive Sleep Apnea

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.

Inclusion criteria

• 18 years or older
• Body Mass Index equal to 32 or less
• Apnea-Hypopnea Index greater than/equal to 10 and less than/equal to 30
• Symptoms of daytime sleepiness

Exclusion criteria

• Septal deviation or nasal obstruction
• Nasal polyps
• Severe seasonal allergies
• Soft palate length insufficient to accommodate implants
• Fujita Modified Mallampati Class 3
• Large tonsils
• Lingual tonsil hypertrophy
• Hypopharyngeal obstruction
• Previous pharyngeal surgery
• Previous upper respiratory tract cancer or radiation therapy
• Active respiratory tract infection
• Dysphagia or speech disorder
• Neurologic disorder
• Unstable psychiatric disorder
• Pregnant or breastfeeding
• History of falling asleep driving or MVA due to sleepiness
• Currently on CPAP therapy or other device for OSA
• Other sleep disorders